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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 K981308
Device Name INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
Applicant
INTERNATIONAL RESPIRATORY SYSTEMS, INC.
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
INTERNATIONAL RESPIRATORY SYSTEMS, INC.
PO BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/10/1998
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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