OTOGRAM
FDA 510(k) clearance K041853 · decided 2004-09-03
Clearance details
- K-number
- K041853
- Device name
- OTOGRAM
- Applicant
- Tympany, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-08
- Decision date
- 2004-09-03
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- ETW
- Device class
- 2
- Regulation number
- 874.3310
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AURICAL HIT (K122028) | Gn Otometrics | 2012-10-23 |
| PRIMUS HEARING INSTRUMENT TEST UNIT (K113831) | Auditdata A/S | 2012-04-19 |
| GN OTOMETRICS TYPE 1053 FREEFIT (K110286) | Gn Otometrics A/S | 2011-04-28 |
| 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/S | 2006-05-03 |
| REM440 (K050496) | Interacoustics A/S, Assens | 2005-04-29 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.