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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 K102226
Device Name DUAL INCU I
Applicant
ATOM MEDICAL CORPORATION
3-18-15 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Applicant Contact TSUYOSHI SUGINO
Correspondent
ATOM MEDICAL CORPORATION
3-18-15 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Correspondent Contact TSUYOSHI SUGINO
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received08/09/2010
Decision Date 01/04/2011
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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