ZZOMA POSITIONAL SLEEPER MODEL 001— 510(k) K100160

Name: FDA 510(k) clearance K100160
Creator: U.S. Food and Drug Administration
Published: 2010-05-11

Substantially Equivalent

Sleep Specialists, LLC

FDA 510(k) clearance K100160 for ZZOMA POSITIONAL SLEEPER MODEL 001, Substantially Equivalent on 2010-05-11. Applicant: Sleep Specialists, LLC. Device class: 2.

Clearance details

Applicant: Sleep Specialists, LLC
Product code: Code MYB
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2010-01-20
Decision date: 2010-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, DE, US

Download summary PDF View on FDA.gov ↗

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