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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 K233827
Device Name OxiWear
Applicant
Oxiwear, Inc.
1111 Arlington Blvd.
#305
Arlington,  VA  22209
Applicant Contact Shavini Fernando
Correspondent
MethodSense, Inc.
1 Copley Pkwy. Suite 130
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received12/01/2023
Decision Date 08/28/2024
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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