Oxxiom

Oximeter

True Wearables, Inc.

The following data is part of a premarket notification filed by True Wearables, Inc. with the FDA for Oxxiom.

Pre-market Notification Details

Device IDK200537
510k NumberK200537
Device Name:Oxxiom
ClassificationOximeter
Applicant True Wearables, Inc. 29826 Avenida De Las Banderas, Suite 300 Rancho Santa Margarita,  CA  92688
ContactMarcelo Lamego
CorrespondentAmy Fowler
Gardner Law, PLLC 423 Main Street Stillwater,  MN  55082
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-03
Decision Date2020-07-03

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