FDA 510(k)

SENSATEC ENDOSCOPIC INSTRUMENTS

K-Number: K942080 · 1994-11-17

Decision Date1994-11-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SENSATEC ENDOSCOPIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K942080. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSATEC ENDOSCOPIC INSTRUMENTS?

SENSATEC ENDOSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Linvatec Corp.. The 510(k) number is K942080.

When did SENSATEC ENDOSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

SENSATEC ENDOSCOPIC INSTRUMENTS received FDA 510(k) clearance on 1994-11-17, under 510(k) number K942080.

Who is the listed applicant for SENSATEC ENDOSCOPIC INSTRUMENTS?

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

What is the FDA product code for SENSATEC ENDOSCOPIC INSTRUMENTS?

The FDA product code for SENSATEC ENDOSCOPIC INSTRUMENTS is GEI.

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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.