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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K243394
Device Name AF531 Oro-Nasal SE Face Mask
Applicant
Respironics Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Applicant Contact Gary LeMere
Correspondent
Respironics Inc.
1001 Murry Ridge Ln
Murrysville,  PA  15668
Correspondent Contact Gary LeMere
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/31/2024
Decision Date 12/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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