FDA 510(k)

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION

K-Number: K912234 · 1991-07-22

Decision Date1991-07-22

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Somnitec, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K912234. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION?

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Somnitec, Inc.. The 510(k) number is K912234.

When did SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION receive FDA 510(k) clearance?

SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION received FDA 510(k) clearance on 1991-07-22, under 510(k) number K912234.

Who is the listed applicant for SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION?

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

What is the FDA product code for SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION?

The FDA product code for SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION is BZG.

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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.