FDA PMA

Automated external defibrillators (non-wearable)

Numéro PMA : P160034 · 2020-03-01

DemandeurZOLL Medical Corporation

Date de décision2020-03-01

Numéro PMAP160034

Code produitMKJ

Classe de dispositifClasse 3

Spécialité médicaleC

Numéro de réglementation21 CFR 8

Comité consultatifCV

Résumé du dispositif

Automated external defibrillators (non-wearable) is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2020-03-01. 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.

Questions fréquentes

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

Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2020-03-01. The listed applicant is ZOLL Medical Corporation.

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 ZOLL Medical Corporation 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.

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Source officielle

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