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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 K924324
Device Name K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
Applicant
K-1 Medical Products, Inc.
9932 Prospect Ave.
Suite 138
Sant Ee,  CA  92071
Applicant Contact ROBERT J KOPOTIC
Correspondent
K-1 Medical Products, Inc.
9932 Prospect Ave.
Suite 138
Sant Ee,  CA  92071
Correspondent Contact ROBERT J KOPOTIC
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
BTI  
Date Received08/27/1992
Decision Date 11/12/1993
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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