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FDA 510(k)

ZOLL E SERIES WITH INTIBATION ASSIST OPTION

K-Number: K080903 · 2008-12-04

ApplicantZOLL Medical Corporation
Decision Date2008-12-04
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL E SERIES WITH INTIBATION ASSIST OPTION 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 2008-12-04 under 510(k) number K080903. 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 E SERIES WITH INTIBATION ASSIST OPTION?

ZOLL E SERIES WITH INTIBATION ASSIST OPTION is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K080903.

When did ZOLL E SERIES WITH INTIBATION ASSIST OPTION receive FDA 510(k) clearance?

ZOLL E SERIES WITH INTIBATION ASSIST OPTION received FDA 510(k) clearance on 2008-12-04, under 510(k) number K080903.

Who is the listed applicant for ZOLL E SERIES WITH INTIBATION ASSIST OPTION?

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 E SERIES WITH INTIBATION ASSIST OPTION?

The FDA product code for ZOLL E SERIES WITH INTIBATION ASSIST OPTION is MKJ. This falls under the Dental category.

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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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