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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 K913394
Device Name INCUBATOR 8000 IC
Applicant
Dragerwerk AG
C/O National Draeger, Inc.
1004 International Dr.
Oakdale,  PA  15071
Applicant Contact STEFAN FREMBGEN
Correspondent
Dragerwerk AG
C/O National Draeger, Inc.
1004 International Dr.
Oakdale,  PA  15071
Correspondent Contact STEFAN FREMBGEN
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received07/30/1991
Decision Date 11/22/1991
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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