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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name incubator, neonatal
510(k) Number K993407
Device Name OHMEDA MEDICAL OMNIBED
Original Applicant
OHMEDA MEDICAL
9065 guilford rd.
columbia,  MD  21046
Original Contact alberto f profumo
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received10/08/1999
Decision Date 01/05/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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