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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Kestra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) 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. The listed applicant is Kestra Medical Technologies, Inc.. The 510(k) number is K233864.

When did ASSURE Wearable ECG receive FDA 510(k) clearance?

ASSURE Wearable ECG received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233864.

Who is the listed applicant for ASSURE Wearable ECG?

The FDA 510(k) record lists Kestra Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSURE Wearable ECG?

The FDA product code for ASSURE Wearable ECG is MWJ.

Other records listing Kestra Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P200037Wearable automated external defibrillator

Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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