Product Code: DRQ FDA class 2 21 CFR 870.2060

Amplifier And Signal Conditioner, Transducer Signal

Cardiovascular

The Transducer Signal Amplifier and Signal Conditioner is a cardiovascular measurement device used to amplify and condition low-level electrical signals from pressure transducers or other sensors before they are processed by monitoring or recording equipment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRQ and it is regulated under 21 CFR 870.2060 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DRQ
Device Class: FDA class 2
Regulation Number: 870.2060
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172216	ACIST RXi Mini System	Aug 18, 2017	Substantially Equivalent	Acist Medical Systems, Inc.
K152693	CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels	Oct 21, 2015	Substantially Equivalent	Boston Scientific Corporation
K150235	CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels	Apr 22, 2015	Substantially Equivalent	Boston Scientific Corporation
K050006	BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO	May 27, 2005	Substantially Equivalent	C.R. Bard, Inc.
K050974	DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS	Apr 29, 2005	Substantially Equivalent	Draeger Medical Systems, Inc.
K033807	INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER	Mar 09, 2004	Substantially Equivalent	Draeger Medical Systems, Inc.
K013205	MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000	Jul 02, 2002	Substantially Equivalent	Millar Instruments, Inc.
K020277	SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER	Feb 19, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K010640	SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER	Mar 20, 2001	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K913875	BARD(R) BIOPOTENTIAL AMPLIFIER II	Nov 27, 1991	Substantially Equivalent	Bard Electrophysiology
K913110	PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED	Oct 10, 1991	Substantially Equivalent	Microwave Medical Systems, Inc.
K910905	SFA-II MICROPROCESSOR-CONTROLLED MODULE	Jul 24, 1991	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K904749	TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200	Mar 01, 1991	Substantially Equivalent	Transtracheal Systems
K901358	BARD BIOPOTENTIAL AMPLIFIER II	May 09, 1990	Substantially Equivalent	C.R. Bard, Inc.
K894295	ASTRO-MED ASC-951 PRESSURE PROCESSOR	Jan 18, 1990	Substantially Equivalent	Astro-Med, Inc.
K885252	MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001	Jan 13, 1989	Substantially Equivalent	Ep Technologies, Inc.
K870783	BPA CARDIOVASCULAR PRESSURE AMPLIFIER	Apr 27, 1987	Substantially Equivalent	Fisher Imaging Corp.
K870728	TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701	Mar 27, 1987	Substantially Equivalent	A&D Engineering, Inc.
K864320	SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE	Feb 20, 1987	Substantially Equivalent	Cordis Corp.
K830914	EXTERNAL VALVE FUNCTION BLOCK	Aug 12, 1983	Substantially Equivalent	Honeywell, Inc.
K803011	DISPOSABLE DIAPHRAGM DONE	Dec 31, 1980	Substantially Equivalent	Sorensen Research
K802961	TRANSDUCER DOME, CAT.#SD-101	Dec 31, 1980	Substantially Equivalent	Sorensen Research
K800488	SURGERY DISPLAY SYSTEM	Apr 16, 1980	Substantially Equivalent	Kent Barker & Assoc.
K792190	MODEL CF-300 THREE CHANNEL FLOW METER	Nov 21, 1979	Substantially Equivalent	Wilton Webster Laboratories
K780571	BLOOD PRESSURE MODULE	May 09, 1978	Substantially Equivalent	C-V Monitors Corp.
K770247	D.C. AMPLIFIER MODULE	Feb 14, 1977	Substantially Equivalent	Mennen Greatbatch Electonics
K761017	PRESSURE MODULE (MODEL P3)	Nov 15, 1976	Substantially Equivalent	Datascope Corp.