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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K060461
Device Name V-505 INFA WARMER
Applicant
Atom Medical, Inc.
Iwakata Bldg. 3rd Floor
3-18-15 Hungo
Tokoyo, Bunkyo-Ku,  JP 1130033
Applicant Contact MARY STANIEWICZ
Correspondent
Atom Medical, Inc.
Iwakata Bldg. 3rd Floor
3-18-15 Hungo
Tokoyo, Bunkyo-Ku,  JP 1130033
Correspondent Contact MARY STANIEWICZ
Regulation Number880.5130
Classification Product Code
FMT  
Date Received02/22/2006
Decision Date 04/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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