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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 K010222
Device Name OHMEDA MEDICAL GIRAFFE INCUBATOR
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact ALBERTO F PROFUMO
Correspondent
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received01/24/2001
Decision Date 03/21/2001
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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