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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
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 Number880.5400
Classification Product Code
FMZ  
Date Received11/19/1997
Decision Date 02/12/1998
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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