Atlas FDA

ETW

46 FDA 510(k) clearances · Product code

72 daysmedian time to decision
140 days90th percentile
46clearances measured

FDA profile

Official device name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3310
Medical specialty
Ear, Nose, Throat
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AURICAL HIT (K122028)Gn Otometrics2012-10-23
PRIMUS HEARING INSTRUMENT TEST UNIT (K113831)Auditdata A/S2012-04-19
GN OTOMETRICS TYPE 1053 FREEFIT (K110286)Gn Otometrics A/S2011-04-28
FONIX ,MODEL 8000 (K093006)Frye Electronics, Inc.2009-12-30
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (K071462)Siemens Hearing Instruments, Inc.2007-06-05
SPEECHLINK 100 TYPE 1053 (K061104)Gn Otometrics A/S2006-05-03
REM440 (K050496)Interacoustics A/S, Assens2005-04-29
OTOGRAM (K041853)Tympany, Inc.2004-09-03
FONIX, MODEL 7000 (K022510)Frye Electronics, Inc.2002-08-27
AUDIOSCAN VERIFIT, MODEL VF-1 (K012306)Etymonic Design, Inc.2001-09-21
FONIX FP35 HEARING AID ANALYZER (K980377)Frye Electronics, Inc.1998-03-18
GSI SA60 DPOAE SYSTEM (K970324)Grason-Stadler, Inc.1997-06-06
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM (K960229)Resound Corp.1996-03-07
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE (K952098)Siemens Hearing Instruments, Inc.1995-05-25
DESKREM-1000 (K943459)Starkey Laboratories, Inc.1994-10-21
PORTAREM 2000 (K943460)Starkey Laboratories, Inc.1994-10-21
INTERACOUSTICS HEARING AID ANALYZER MS 40 (K943607)Precision Acoustics Ind., Inc.1994-09-23
INTERACOUSTICS. HEARING AID ANALYZER (K941848)Precision Acoustics Ind., Inc.1994-05-23
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM (K934342)Glaser Instruments AG1994-01-21
FONIX 3500 HEARING AID ANALYZER (K935400)Frye Electronics, Inc.1994-01-14
RASTRONICS CCI 8 (K902244)Rastronics USA, Inc.1990-10-05
RASTRONICS CCI 10/3 HEARING AID ANALYSIS (K902252)Rastronics USA, Inc.1990-09-12
CAS (COMPUTERIZED ANALYZER SYSTEM) (K896996)Gn Danavox, Inc.1990-08-09
NICOLET REAL EAR ANALYZER (K896477)Nicolet Instrument Corp.1990-02-08
TYPE FP40 DIGITAL HEARING AID ANALYZER (K895383)Frye Electronics, Inc.1990-01-22
MODEL 340 PROBE MIC SYSTEM (K896301)Virtual Corp.1990-01-16
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM (K884371)Madsen Electronics (Canada) , Ltd.1989-02-13
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500 (K884046)Etymonic Design, Inc.1989-02-13
MADSEN IGO1500 INSERTION GAIN OPTIMIZER (K884372)Madsen Electronics (Canada) , Ltd.1989-02-13
MASTER-FIT HEARING EVALUA. & RECOM. (HEAR) SYSTEM (K872633)Hearing Health Care Program1987-09-16
TYPE 6400 REAL EAR HEARING AID ANALYZER (K872242)Frye Electronics, Inc.1987-07-10
AUDIOMETER (K870337)Bio-Logic Systems Corp.1987-04-16
HEARING AID TEST SYSTEM MODEL HAT 1000 (K870229)Madsen Electronics (Canada) , Ltd.1987-03-13
HA-2000 REAL EAR SPECTROSCOPE (K862026)And/Or Corp.1986-08-15
PHONIC EAR, MODEL PE 1800 (K862162)Phonic Ear, Inc.1986-07-18
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823 (K862086)A/S Bruel & Kjaer1986-07-16
PHONIC EAR (K861857)Phonic Ear, Inc.1986-06-09
TYPE 6500 HEARING AID ANALYZER (K861571)Frye Electronics, Inc.1986-05-30
ER-7C CLINICAL PROBE MICROPHONE (K861113)Etymotic Research1986-04-23
INSERTION GAIN OPTIMIZER IGO-1000 (K854535)Madsen Electronics (Canada) , Ltd.1986-02-20
HEARING AID ANALYSIS SYSTEM (K853271)Robert Bosch Corp.1986-01-16
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 (K853320)Rastronics USA, Inc.1985-09-27
TYPE FP30 DIGITAL HEARING AID ANALYZER (K850918)Frye Electronics, Inc.1985-05-29
STARKET MODEL HMS (K844275)Starkey Laboratories, Inc.1984-12-03
STARKEY MODEL HAL-1 (K821908)Starkey Laboratories, Inc.1982-08-03
FONIX TYPE 5100 HEARING AID ANALYZER (K801905)Frye Electronics, Inc.1980-08-27

Track ETW automatically

Every clearance here is in the API, with alerts when new ones post.