ULTIMA SNORING MIKE, MODEL 0540— 510(k) K020312

Name: FDA 510(k) clearance K020312
Creator: U.S. Food and Drug Administration
Published: 2002-08-07

Substantially Equivalent

Braebon Medical Corp.

FDA 510(k) clearance K020312 for ULTIMA SNORING MIKE, MODEL 0540, Substantially Equivalent on 2002-08-07. Applicant: Braebon Medical Corp.. Device class: 2.

Clearance details

Applicant: Braebon Medical Corp.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2002-01-30
Decision date: 2002-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carp, Ontario, CA

Download summary PDF View on FDA.gov ↗

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