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FDA 510(k)

GSI 2000 MIDDLE EAR ANALYZER

K-Number: K000097 · 2000-04-12

ApplicantGrason-Stadler, Inc.
Decision Date2000-04-12
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI 2000 MIDDLE EAR ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 2000-04-12 under 510(k) number K000097. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI 2000 MIDDLE EAR ANALYZER?

GSI 2000 MIDDLE EAR ANALYZER is a medical device that received FDA 510(k) clearance on 2000-04-12. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K000097.

When did GSI 2000 MIDDLE EAR ANALYZER receive FDA 510(k) clearance?

GSI 2000 MIDDLE EAR ANALYZER received FDA 510(k) clearance on 2000-04-12, under 510(k) number K000097.

Who is the listed applicant for GSI 2000 MIDDLE EAR ANALYZER?

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

What is the FDA product code for GSI 2000 MIDDLE EAR ANALYZER?

The FDA product code for GSI 2000 MIDDLE EAR ANALYZER is ETY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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