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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 K870222
Device Name AMEDA AMECARE(R) NEONATAL INCUBATOR
Applicant
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
Hollister, Inc.
C/O Burdit,Radzius,Chartered
333 W.Wacker Dr.
Chicago,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received01/21/1987
Decision Date 06/10/1987
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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