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FDA 510(k)

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

K-Number: K110526 · 2011-03-25

ApplicantZOLL Medical Corporation
Decision Date2011-03-25
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE 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 2011-03-25 under 510(k) number K110526. 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 AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE?

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE is a medical device that received FDA 510(k) clearance on 2011-03-25. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K110526.

When did ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE receive FDA 510(k) clearance?

ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE received FDA 510(k) clearance on 2011-03-25, under 510(k) number K110526.

Who is the listed applicant for ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE?

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 AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE?

The FDA product code for ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE 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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