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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 K940581
Device Name BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact RICHARD G CONFER
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact RICHARD G CONFER
Regulation Number868.5915
Classification Product Code
BTM  
Date Received02/08/1994
Decision Date 05/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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