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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K833748
Device Name RESCUE VALVE
Applicant
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Correspondent
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/26/1983
Decision Date 12/08/1983
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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