FDA 510(k) Application Details - K974349

Device Classification Name Incubator, Neonatal

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510(K) Number K974349
Device Name Incubator, Neonatal
Applicant OHMEDA MEDICAL
9065 GUILFORD RD.
COLUMBIA, MD 21046 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 11/19/1997
Decision Date 02/12/1998
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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