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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 K912921
Device Name VSI 1000
Applicant
Vitaltrends Technology, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact GEORGE M BASKINGER
Correspondent
Vitaltrends Technology, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact GEORGE M BASKINGER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received07/03/1991
Decision Date 10/30/1992
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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