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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 K251847
Device Name Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
Applicant
Sleepnet Corporation
5 Merrill Industrial Dr.
Hampton,  NH  03842
Applicant Contact Jennifer Kennedy
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Todd Courtney
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/16/2025
Decision Date 01/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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