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FDA 510(k)

VIVAPORE 2

K-Number: K943966 · 1995-04-11

ApplicantVivascience, Inc.
Decision Date1995-04-11
Product CodeJJH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIVAPORE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Vivascience, Inc.. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K943966. The device is classified under product code JJH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVAPORE 2?

VIVAPORE 2 is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Vivascience, Inc.. The 510(k) number is K943966.

When did VIVAPORE 2 receive FDA 510(k) clearance?

VIVAPORE 2 received FDA 510(k) clearance on 1995-04-11, under 510(k) number K943966.

Who is the listed applicant for VIVAPORE 2?

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

What is the FDA product code for VIVAPORE 2?

The FDA product code for VIVAPORE 2 is JJH.

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 Vivascience, 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.

K960298VIVASPIN 4 10,000 MWK943965VIVAPORE 10

Related Devices (Code: JJH)

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.

K113731ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.K960298VIVASPIN 4 10,000 MWVivascience, Inc.K943965VIVAPORE 10Vivascience, Inc.K941326ULTRAFREE-CLMillipore Corp.K935496NANOSEP N10Intersep , Ltd.K930168CENTRICON -50 CONCENTRATORAmicon, 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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