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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 K895550
Device Name K-1 INFANT TRANSPORT SYSTEM
Applicant
K-1 Medical Products, Inc.
1848 Commercial St.
San Diego,  CA  92113
Applicant Contact DAVID M PRICE
Correspondent
K-1 Medical Products, Inc.
1848 Commercial St.
San Diego,  CA  92113
Correspondent Contact DAVID M PRICE
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received09/13/1989
Decision Date 12/07/1989
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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