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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K102442
Device Name E.S.O. (ELECTRO SENSOR OXI)
Applicant
L.D. TECHNOLOGY, LLC
100 N. BISCAYNE BLVD
SUITE 500
MIAMI,  FL  33132
Applicant Contact ALBERT MAAREK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
MWI  
Date Received08/26/2010
Decision Date 09/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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