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FDA 510(k)

BIO-BINKI

K-Number: K961782 · 1997-03-28

ApplicantBiomni Medical Systems, Inc.
Decision Date1997-03-28
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIO-BINKI is the device name listed in this FDA 510(k) record. The listed applicant is Biomni Medical Systems, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K961782. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-BINKI?

BIO-BINKI is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Biomni Medical Systems, Inc.. The 510(k) number is K961782.

When did BIO-BINKI receive FDA 510(k) clearance?

BIO-BINKI received FDA 510(k) clearance on 1997-03-28, under 510(k) number K961782.

Who is the listed applicant for BIO-BINKI?

The FDA 510(k) record lists Biomni Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-BINKI?

The FDA product code for BIO-BINKI is JAA.

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 Biomni Medical Systems, Inc. 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.

K914215SELECTACUT BIOPSY DEVICE

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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