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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K083229
Device Name E.S TECK ( ELECTRO SENSOR TECK)
Applicant
Ld Technology, LLC
11459 NW 34 St.
Miami,  FL  33178
Applicant Contact RICHARD CLEMENT
Correspondent
Ld Technology, LLC
11459 NW 34 St.
Miami,  FL  33178
Correspondent Contact RICHARD CLEMENT
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DPS   DQA   JOM  
Date Received11/03/2008
Decision Date 02/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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