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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 K862921
Device Name MODEL 10200 PREMATURE INFANT INCUBATOR
Applicant
Rotem Industries C/O Medsys, Inc.
201 Rte. 17
Rutherford,  NJ  07070
Applicant Contact MYERS, PHD
Correspondent
Rotem Industries C/O Medsys, Inc.
201 Rte. 17
Rutherford,  NJ  07070
Correspondent Contact MYERS, PHD
Regulation Number880.5130
Classification Product Code
FMT  
Date Received08/01/1986
Decision Date 04/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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