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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 K163382
Device Name Oxitone 1000
Oxitone Medical Ltd.
17 Atir Yeda Street
Kfar Saba,  IL 4464312
Applicant Contact Leon Eisen
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
Date Received12/01/2016
Decision Date 05/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No