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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 K191574
Device Name OxSAT 100
Applicant
S.L.P. , Ltd.
62 Anilewicz St.
Tel-Aviv,  IL 67060
Applicant Contact Avi Yosef
Correspondent
S.L.P. Ltd. C/O Promedic, LLC
131 Bay Point Dr. Ne.
St Petersburg,  FL  67060
Correspondent Contact Paul Dryden
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/14/2019
Decision Date 04/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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