ASSURE Wearable ECG
K-Number: K233864 · 2024-05-07
ApplicantKestra Medical Technologies, Inc.
Decision Date2024-05-07
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ASSURE Wearable ECG is a medical device manufactured by Kestra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-05-07 under approval number K233864. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ASSURE Wearable ECG?
ASSURE Wearable ECG is a medical device that received FDA 510(k) clearance on 2024-05-07. It is manufactured by Kestra Medical Technologies, Inc.. The 510(k) number is K233864.
When was ASSURE Wearable ECG approved by the FDA?
ASSURE Wearable ECG received FDA 510(k) clearance on 2024-05-07, under approval number K233864.
What company makes ASSURE Wearable ECG?
ASSURE Wearable ECG is manufactured by Kestra Medical Technologies, Inc..
What is the FDA product code for ASSURE Wearable ECG?
The FDA product code for ASSURE Wearable ECG is MWJ.
Other Devices by Kestra Medical Technologies, Inc.
Related Devices (Code: MWJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.