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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
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