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FDA 510(k)

BARD(R) BIOPOTENTIAL AMPLIFIER II

K-Number: K913875 · 1991-11-27

ApplicantBard Electrophysiology
Decision Date1991-11-27
Product CodeDRQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD(R) BIOPOTENTIAL AMPLIFIER II is the device name listed in this FDA 510(k) record. The listed applicant is Bard Electrophysiology. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K913875. The device is classified under product code DRQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD(R) BIOPOTENTIAL AMPLIFIER II?

BARD(R) BIOPOTENTIAL AMPLIFIER II is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Bard Electrophysiology. The 510(k) number is K913875.

When did BARD(R) BIOPOTENTIAL AMPLIFIER II receive FDA 510(k) clearance?

BARD(R) BIOPOTENTIAL AMPLIFIER II received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913875.

Who is the listed applicant for BARD(R) BIOPOTENTIAL AMPLIFIER II?

The FDA 510(k) record lists Bard Electrophysiology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD(R) BIOPOTENTIAL AMPLIFIER II?

The FDA product code for BARD(R) BIOPOTENTIAL AMPLIFIER II is DRQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bard Electrophysiology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042105CLIPPER DIAGNOSTIC ELECTRODE CATHETERK893611BARD PLAQUE ELECTRODE ARRAY

Related Devices (Code: DRQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172216ACIST RXi Mini SystemAcist Medical Systems, Inc.K050006BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIOC.R. Bard, Inc.K050974DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSDraeger Medical Systems, Inc.K033807INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTERDraeger Medical Systems, Inc.K013205MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000Millar Instruments, Inc.K020277SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTERSiemens Medical Solutions USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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