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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
Applicant
True Wearables, Inc.
29826 Avenida De Las Banderas, Suite 300
Rancho Santa Margarita,  CA  92688
Applicant Contact Marcelo Lamego
Correspondent
Gardner Law Pllc
423 Main St.
Stillwater,  MN  55082
Correspondent Contact Amy Fowler
Regulation Number870.2700
Classification Product Code
DQA  
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
Predetermined Change
Control Plan Authorized		 No
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