SOMNIMIC (R)— 510(k) K912817

Substantially Equivalent

Somnitec, Inc.

FDA 510(k) clearance K912817 for SOMNIMIC (R), Substantially Equivalent on 1991-07-26. Applicant: Somnitec, Inc.. Device class: 2.

Clearance details

Applicant: Somnitec, Inc.
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1991-05-21
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Somnitec, Inc.

K911989 — GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.1991-07-30
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Data sourced from openFDA. This site is unofficial and independent of the FDA.