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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 K974349
Device Name OHMEDA-OHIO CARE PLUS INCUBATOR
Original Applicant
OHMEDA MEDICAL
9065 guilford rd.
columbia,  MD  21046
Original Contact alberto f profumo
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received11/19/1997
Decision Date 02/12/1998
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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