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FDA PMA

Wearable automated external defibrillator

PMA Number: P200037 · 2026-09-28

ApplicantKestra Medical Technologies, Inc.
Decision Date2026-09-28
PMA NumberP200037
Product CodeMVK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Wearable automated external defibrillator 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 2026-09-28. The device is classified under product code MVK. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Wearable automated external defibrillator?

Wearable automated external defibrillator is a medical device that received FDA 510(k) clearance on 2026-09-28. The listed applicant is Kestra Medical Technologies, Inc..

When did Wearable automated external defibrillator receive FDA 510(k) clearance?

The clearance date for Wearable automated external defibrillator can be found in the official FDA records.

Who is the listed applicant for Wearable automated external defibrillator?

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 Wearable automated external defibrillator?

The FDA product code for Wearable automated external defibrillator is MVK.

Related Clinical Trials

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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