FDA 510(k) Application Details - K102279

Device Classification Name Incubator, Neonatal

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510(K) Number K102279
Device Name Incubator, Neonatal
Applicant ATOM MEDICAL CORPORATION
3-18-15 HONGO
BUNKYO-KU, TOKYO 113-0033 JP
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Contact TSUYOSHI SUGINO
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Regulation Number 880.5400

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Classification Product Code FMZ
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Date Received 08/11/2010
Decision Date 12/29/2010
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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