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FDA PMA

Automated external defibrillators (non-wearable)

PMA Number: P160032 · 2026-08-25

ApplicantDefibtech, LLC
Decision Date2026-08-25
PMA NumberP160032
Product CodeMKJ
Device ClassClass 3
Medical SpecialtyC
Regulation Number21 CFR 8
Advisory CommitteeCV

Device Summary

Automated external defibrillators (non-wearable) is the device name listed in this FDA 510(k) record. The listed applicant is Defibtech, LLC. It received FDA 510(k) clearance on 2026-08-25. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements.

Frequently Asked Questions

What is the Automated external defibrillators (non-wearable)?

Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Defibtech, LLC.

When did Automated external defibrillators (non-wearable) receive FDA 510(k) clearance?

The clearance date for Automated external defibrillators (non-wearable) can be found in the official FDA records.

Who is the listed applicant for Automated external defibrillators (non-wearable)?

The FDA 510(k) record lists Defibtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automated external defibrillators (non-wearable)?

The FDA product code for Automated external defibrillators (non-wearable) is MKJ. This falls under the Dental category.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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