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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 K200141
Device Name Oxi-W System
Applicant
LD Technology LLC
100 N. Biscayne Blvd Suite 502
Miami,  FL  33132
Applicant Contact Albert MAAREK
Correspondent
LD Technology LLC
100 N. Biscayne Blvd Suite 502
Miami,  FL  33132
Correspondent Contact Albert MAAREK
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/21/2020
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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