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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 K971243
Device Name OHMEDA INFANT RESUSCITATION SYSTEM
Applicant
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact ALBERTO F PROFUMO
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/03/1997
Decision Date 12/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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