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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K851924
Device Name LITEGUARD 9
Applicant
Temtech , Ltd.
8 Balloo Dr.
Balloo Industrial Estate
Bangot,Co. Down Bt192qy,  IE
Applicant Contact ANDREW O'HARA
Correspondent
Temtech , Ltd.
8 Balloo Dr.
Balloo Industrial Estate
Bangot,Co. Down Bt192qy,  IE
Correspondent Contact ANDREW O'HARA
Regulation Number870.5300
Classification Product Code
LDD  
Date Received05/02/1985
Decision Date 08/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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