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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 K200537
Device Name Oxxiom
True Wearables, Inc.
29826 Avenida de Las Banderas, Suite 300
Rancho Santa Margarita,  CA  92688
Applicant Contact Marcelo Lamego
Gardner Law, PLLC
423 Main Street
Stillwater,  MN  55082
Correspondent Contact Amy Fowler
Regulation Number870.2700
Classification Product Code
Date Received03/03/2020
Decision Date 07/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No