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FDA PMA

Over-the-counter automated external defibrillator

PMA Number: P160029 · 2026-02-02

ApplicantPhilips Medical Systems, Inc.
Decision Date2026-02-02
PMA NumberP160029
Product CodeNSA
Device ClassClass 3
Medical SpecialtyC
Regulation Number21 CFR 8
Advisory CommitteeCV

Device Summary

Over-the-counter automated external defibrillator is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-02. The device is classified under product code NSA. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Over-the-counter automated external defibrillator?

Over-the-counter automated external defibrillator is a medical device that received FDA 510(k) clearance on 2026-02-02. The listed applicant is Philips Medical Systems, Inc..

When did Over-the-counter automated external defibrillator receive FDA 510(k) clearance?

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

Who is the listed applicant for Over-the-counter automated external defibrillator?

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

What is the FDA product code for Over-the-counter automated external defibrillator?

The FDA product code for Over-the-counter automated external defibrillator is NSA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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