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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 K912000
Device Name TYPE INTERFACE 9271/1 INCUBATOR/WARMER
Applicant
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Applicant Contact LISBETH ISBRANDT
Correspondent
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Correspondent Contact LISBETH ISBRANDT
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received04/24/1991
Decision Date 09/21/1992
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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