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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K842693
Device Name RESPIRONICS VENTEASY
Applicant
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Correspondent
RESPIRONICS, INC.
530 SECO RD.
MONROEVILLE,  PA  15146
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/11/1984
Decision Date 08/10/1984
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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