Atlas FDA

DRR

24 FDA 510(k) clearances · Product code

31 daysmedian time to decision
135 days90th percentile
24clearances measured

FDA profile

Official device name
Amplifier And Signal Conditioner, Biopotential
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2050
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 3 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (K022660)Biocheck, Inc.2002-12-19
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (K971570)Quinton Electrophysiology Corp.1997-12-29
EP AMP, MODEL #901 (K925346)Quinton Electrophysiology Corp.1993-04-30
HORIZON 9000/HIS OPTION AMPLIFIER (K914381)Mennen Medical, Inc.1992-01-28
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (K911935)Gould, Inc.1991-07-22
CARDIOLAB AMPLIFIER MODULE (CAM) (K910307)Prucka Engineering, Inc.1991-04-12
ASC-952 PHYSIOLOGICAL AMPLIFIER (K894735)Astro-Med, Inc.1989-09-18
ASC-950 ECG AMPLIFIER (K894161)Astro-Med, Inc.1989-08-03
BARD BIOPOTENTIAL AMPLIFIER (K874441)C.R. Bard, Inc.1988-01-19
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (K853652)Fisher Imaging Corp.1986-01-16
EPC FILTER (K813123)Codman & Shurtleff, Inc.1981-11-27
NON-INVASIVE AMPLIFIER (K810828)Henry Ford Hospital1981-04-10
HP MODEL 8880A FILTER (K802686)Hewlett-Packard Co.1980-11-26
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K802282)Consolidated Medical Equipment, Inc.1980-10-10
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K792283)Arzbaecher & Co.1979-11-21
MODEL 15055A MAINFRAME (K791964)Hewlett-Packard Co.1979-10-11
INTERVAL TIMER MODEL V4295 (K790203)Electronics For Medicine, Inc.1979-03-02
DCG PREAMPLIFIER MODULE (K780572)C-V Monitors Corp.1978-05-09
ESIS MODULE (K780043)Datascope Corp.1978-02-13
AMPLIFIER MODULE, 78211A ECG (K772132)Hewlett-Packard Co.1977-11-22
ECG AMPLIFIER/R WAVE TRIGGER (K771976)G.D. Searle and Co.1977-11-09
PATIENT MONITORS MODELS 78701A/78702A (K771572)Hewlett-Packard Co.1977-08-30
ELGILOY STYLET (K770243)Cardiac Pacemakers, Inc.1977-02-14
DISPLAY MONITOR (MODEL 78301A) (K761056)Hewlett-Packard Co.1976-12-09

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