SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION— 510(k) K912234

Name: FDA 510(k) clearance K912234
Creator: U.S. Food and Drug Administration
Published: 1991-07-22

Substantially Equivalent

Somnitec, Inc.

FDA 510(k) clearance K912234 for SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION, Substantially Equivalent on 1991-07-22. Applicant: Somnitec, Inc.. Device class: 2.

Clearance details

Applicant: Somnitec, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1991-05-17
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

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