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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 K231313
Device Name Therapy Mask 3100 NC/SP
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Shipra Gulati
Correspondent
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact Shipra Gulati
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/05/2023
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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