SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM— 510(k) K110064

Name: FDA 510(k) clearance K110064
Creator: U.S. Food and Drug Administration
Published: 2011-03-18

Substantially Equivalent

Snap Diagnostics, LLC

FDA 510(k) clearance K110064 for SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM, Substantially Equivalent on 2011-03-18. Applicant: Snap Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Snap Diagnostics, LLC
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2011-01-10
Decision date: 2011-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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