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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K964401
Device Name KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
Applicant
Ludlow Technical Products
Two Ludlow Park
Chicopee,  MA  01022
Applicant Contact PATRICK A MALIA
Correspondent
Ludlow Technical Products
Two Ludlow Park
Chicopee,  MA  01022
Correspondent Contact PATRICK A MALIA
Regulation Number880.5130
Classification Product Code
FMT  
Date Received11/04/1996
Decision Date 02/06/1997
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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