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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K843889
Device Name RESPIRONICS SLEEPEASY NASAL CPAP SYS
Applicant
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Applicant Contact EUGENE SCARBERRY
Correspondent
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Correspondent Contact EUGENE SCARBERRY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received10/02/1984
Decision Date 12/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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