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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 K900752
Device Name INCUBATOR 8000
Applicant
Dragerwerk AG
101 Technology Dr., P.O. Box
120
Pittsburgh,  PA  15230
Applicant Contact STEFAN FREMBGEN
Correspondent
Dragerwerk AG
101 Technology Dr., P.O. Box
120
Pittsburgh,  PA  15230
Correspondent Contact STEFAN FREMBGEN
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received02/16/1990
Decision Date 08/02/1990
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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