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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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