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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K884160
Device Name OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
Applicant
OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA,  MD  21046
Applicant Contact F PROFUMO
Correspondent
OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA,  MD  21046
Correspondent Contact F PROFUMO
Regulation Number880.5130
Classification Product Code
FMT  
Date Received10/04/1988
Decision Date 11/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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