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FDA 510(k)

UNISURGE INTERFACE P

K-Number: K972178 · 1997-09-05

ApplicantUnisurge Holding, Inc.
Decision Date1997-09-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNISURGE INTERFACE P is the device name listed in this FDA 510(k) record. The listed applicant is Unisurge Holding, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972178. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISURGE INTERFACE P?

UNISURGE INTERFACE P is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Unisurge Holding, Inc.. The 510(k) number is K972178.

When did UNISURGE INTERFACE P receive FDA 510(k) clearance?

UNISURGE INTERFACE P received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972178.

Who is the listed applicant for UNISURGE INTERFACE P?

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

What is the FDA product code for UNISURGE INTERFACE P?

The FDA product code for UNISURGE INTERFACE P is GCJ.

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Related Devices (Code: GCJ)

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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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