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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K833328
Device Name RESPIRONICS RESCUE DOME
Applicant
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number868.5110
Classification Product Code
CAE  
Date Received09/27/1983
Decision Date 12/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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