MICHELE SLEEP SCORING SYSTEMS— 510(k) K112102

Name: FDA 510(k) clearance K112102
Creator: U.S. Food and Drug Administration
Published: 2011-12-20

Substantially Equivalent

Younes Sleep Technologies

FDA 510(k) clearance K112102 for MICHELE SLEEP SCORING SYSTEMS, Substantially Equivalent on 2011-12-20. Applicant: Younes Sleep Technologies. Device class: 2.

Clearance details

Applicant: Younes Sleep Technologies
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2011-07-22
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winnipeg, Manitoba, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.