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FDA 510(k)

GSI 37 AUTO TYMP

K-Number: K911095 · 1991-03-29

ApplicantLucas Grason-Stadler, Inc.
Decision Date1991-03-29
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI 37 AUTO TYMP is the device name listed in this FDA 510(k) record. The listed applicant is Lucas Grason-Stadler, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K911095. 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 37 AUTO TYMP?

GSI 37 AUTO TYMP is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Lucas Grason-Stadler, Inc.. The 510(k) number is K911095.

When did GSI 37 AUTO TYMP receive FDA 510(k) clearance?

GSI 37 AUTO TYMP received FDA 510(k) clearance on 1991-03-29, under 510(k) number K911095.

Who is the listed applicant for GSI 37 AUTO TYMP?

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

What is the FDA product code for GSI 37 AUTO TYMP?

The FDA product code for GSI 37 AUTO TYMP is ETY.

Other records listing Lucas Grason-Stadler, 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.

K934658GSI 60 DPOAE SYSTEMK925585GSI 38 AUTO TYMP

Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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