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FDA 510(k)

GEMINI STANDARD AND MINI VALVES

K-Number: K974708 · 1998-03-10

ApplicantNeurocare Group
Decision Date1998-03-10
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GEMINI STANDARD AND MINI VALVES is the device name listed in this FDA 510(k) record. The listed applicant is Neurocare Group. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K974708. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMINI STANDARD AND MINI VALVES?

GEMINI STANDARD AND MINI VALVES is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Neurocare Group. The 510(k) number is K974708.

When did GEMINI STANDARD AND MINI VALVES receive FDA 510(k) clearance?

GEMINI STANDARD AND MINI VALVES received FDA 510(k) clearance on 1998-03-10, under 510(k) number K974708.

Who is the listed applicant for GEMINI STANDARD AND MINI VALVES?

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

What is the FDA product code for GEMINI STANDARD AND MINI VALVES?

The FDA product code for GEMINI STANDARD AND MINI VALVES is JXG.

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Official Source

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