FDA 510(k) Application Details - K020547

Device Classification Name Incubator, Neonatal

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510(K) Number K020547
Device Name Incubator, Neonatal
Applicant OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL, MD 20723 US
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Contact ALBERTO F PROFUMO
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Regulation Number 880.5400

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Classification Product Code FMZ
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Date Received 02/19/2002
Decision Date 05/09/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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