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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 K901157
Device Name MP4, MP4SI, IT4 INCUBATORS
Applicant
Mediprema
Bird Airlodge
P.O. Box 817
Sandpoint,  ID  83864
Applicant Contact BIRD, MD
Correspondent
Mediprema
Bird Airlodge
P.O. Box 817
Sandpoint,  ID  83864
Correspondent Contact BIRD, MD
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received03/13/1990
Decision Date 03/27/1991
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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