SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.— 510(k) K904117

Name: FDA 510(k) clearance K904117
Creator: U.S. Food and Drug Administration
Published: 1991-02-25

Substantially Equivalent

Dawn Medical

FDA 510(k) clearance K904117 for SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST., Substantially Equivalent on 1991-02-25. Applicant: Dawn Medical. Device class: 2.

Clearance details

Applicant: Dawn Medical
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1990-09-06
Decision date: 1991-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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