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FDA 510(k)

ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO

K-Number: K071025 · 2007-06-22

ApplicantZoll Medical Corporation, World Wide Headquarters
Decision Date2007-06-22
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Medical Corporation, World Wide Headquarters. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K071025. 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 SEE-THRU CPR, MODEL AEDPRO?

ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Zoll Medical Corporation, World Wide Headquarters. The 510(k) number is K071025.

When did ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO receive FDA 510(k) clearance?

ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO received FDA 510(k) clearance on 2007-06-22, under 510(k) number K071025.

Who is the listed applicant for ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO?

The FDA 510(k) record lists Zoll Medical Corporation, World Wide Headquarters as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO?

The FDA product code for ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO is MKJ. This falls under the Dental category.

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Other records listing Zoll Medical Corporation, World Wide Headquarters 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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