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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 K920049
Device Name MEDIX PC-305 NEONATAL INCUBATOR
Applicant
Medix I.C.S.A.
Calle 89 Jose Arias 293
San Martin, Buenos Aires,  AR B1672ACA
Applicant Contact CARLOS GUERRA
Correspondent
Medix I.C.S.A.
Calle 89 Jose Arias 293
San Martin, Buenos Aires,  AR B1672ACA
Correspondent Contact CARLOS GUERRA
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received01/06/1992
Decision Date 05/21/1993
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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