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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 K201439
Device Name Ventilator, Non-continuous (Respirator)
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Jennifer Richardson
Correspondent
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact Jennifer Richardson
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Codes
CAW   CBK   MNR   MNS   MNT  
NOU   OLZ  
Date Received06/01/2020
Decision Date 09/25/2020
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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