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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K151683
Device Name SleepWeaver Advance Pediatric Nasal CPAP Mask
Applicant
Circadiance, LLC
1060 Corporate Ln.
Export,  PA  15632
Applicant Contact David Groll
Correspondent
Regulatory & Quality Solutions, LLC
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Pooja Roychoudhury
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/22/2015
Decision Date 04/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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