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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 K210386
Device Name Magneto Nasal Mask
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Applicant Contact Anna Danley
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Correspondent Contact Anna Danley
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/09/2021
Decision Date 07/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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