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FDA 510(k)

VIVASPIN 4 10,000 MW

K-Number: K960298 · 1996-03-19

ApplicantVivascience, Inc.
Decision Date1996-03-19
Product CodeJJH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIVASPIN 4 10,000 MW is the device name listed in this FDA 510(k) record. The listed applicant is Vivascience, Inc.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K960298. 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 VIVASPIN 4 10,000 MW?

VIVASPIN 4 10,000 MW is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Vivascience, Inc.. The 510(k) number is K960298.

When did VIVASPIN 4 10,000 MW receive FDA 510(k) clearance?

VIVASPIN 4 10,000 MW received FDA 510(k) clearance on 1996-03-19, under 510(k) number K960298.

Who is the listed applicant for VIVASPIN 4 10,000 MW?

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 VIVASPIN 4 10,000 MW?

The FDA product code for VIVASPIN 4 10,000 MW 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.

K943965VIVAPORE 10K943966VIVAPORE 2

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.K943966VIVAPORE 2Vivascience, 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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