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FDA 510(k)

VIPOR UNIT

K-Number: K964322 · 1997-02-26

ApplicantTilane Corp.
Decision Date1997-02-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIPOR UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Tilane Corp.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K964322. 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 VIPOR UNIT?

VIPOR UNIT is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Tilane Corp.. The 510(k) number is K964322.

When did VIPOR UNIT receive FDA 510(k) clearance?

VIPOR UNIT received FDA 510(k) clearance on 1997-02-26, under 510(k) number K964322.

Who is the listed applicant for VIPOR UNIT?

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

What is the FDA product code for VIPOR UNIT?

The FDA product code for VIPOR UNIT 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 Tilane Corp. 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.

K920746VFC UNIT

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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