Atlas FDA

DRQ

27 FDA 510(k) clearances · Product code

43 daysmedian time to decision
144 days90th percentile
27clearances measured

FDA profile

Official device name
Amplifier And Signal Conditioner, Transducer Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2060
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1 · 2003: 2 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ACIST RXi Mini System (K172216)Acist Medical Systems, Inc.2017-08-18
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (K152693)Boston Scientific Corporation2015-10-21
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235)Boston Scientific Corporation2015-04-22
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO (K050006)C.R. Bard, Inc.2005-05-27
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (K050974)Draeger Medical Systems, Inc.2005-04-29
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (K033807)Draeger Medical Systems, Inc.2004-03-09
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (K013205)Millar Instruments, Inc.2002-07-02
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER (K020277)Siemens Medical Solutions USA, Inc.2002-02-19
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (K010640)Siemens Medical Solutions USA, Inc.2001-03-20
BARD(R) BIOPOTENTIAL AMPLIFIER II (K913875)Bard Electrophysiology1991-11-27
PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (K913110)Microwave Medical Systems, Inc.1991-10-10
SFA-II MICROPROCESSOR-CONTROLLED MODULE (K910905)Life Sciences Manufacturing, Inc.1991-07-24
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (K904749)Transtracheal Systems1991-03-01
BARD BIOPOTENTIAL AMPLIFIER II (K901358)C.R. Bard, Inc.1990-05-09
ASTRO-MED ASC-951 PRESSURE PROCESSOR (K894295)Astro-Med, Inc.1990-01-18
MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 (K885252)Ep Technologies, Inc.1989-01-13
BPA CARDIOVASCULAR PRESSURE AMPLIFIER (K870783)Fisher Imaging Corp.1987-04-27
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 (K870728)A&D Engineering, Inc.1987-03-27
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE (K864320)Cordis Corp.1987-02-20
EXTERNAL VALVE FUNCTION BLOCK (K830914)Honeywell, Inc.1983-08-12
DISPOSABLE DIAPHRAGM DONE (K803011)Sorensen Research1980-12-31
TRANSDUCER DOME, CAT.#SD-101 (K802961)Sorensen Research1980-12-31
SURGERY DISPLAY SYSTEM (K800488)Kent Barker & Assoc.1980-04-16
MODEL CF-300 THREE CHANNEL FLOW METER (K792190)Wilton Webster Laboratories1979-11-21
BLOOD PRESSURE MODULE (K780571)C-V Monitors Corp.1978-05-09
D.C. AMPLIFIER MODULE (K770247)Mennen Greatbatch Electonics1977-02-14
PRESSURE MODULE (MODEL P3) (K761017)Datascope Corp.1976-11-15

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