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FDA 510(k)

ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE

K-Number: K091561 · 2010-09-23

ApplicantZOLL Medical Corporation
Decision Date2010-09-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE 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 2010-09-23 under 510(k) number K091561. 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. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE?

ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE is a medical device that received FDA 510(k) clearance on 2010-09-23. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K091561.

When did ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE receive FDA 510(k) clearance?

ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE received FDA 510(k) clearance on 2010-09-23, under 510(k) number K091561.

Who is the listed applicant for ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE?

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 ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE?

The FDA product code for ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE is MKJ. This falls under the Dental category.

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Other records listing ZOLL Medical Corporation as applicant

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Related Devices (Code: MKJ)

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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