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FDA 510(k)

ZOLL E SERIES 12SL, ANALYSIS OPTION

K-Number: K080232 · 2008-04-23

ApplicantZoll Medical Corporation, World Wide Headquarters
Decision Date2008-04-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL E SERIES 12SL, ANALYSIS OPTION 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 2008-04-23 under 510(k) number K080232. 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 12SL, ANALYSIS OPTION?

ZOLL E SERIES 12SL, ANALYSIS OPTION is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Zoll Medical Corporation, World Wide Headquarters. The 510(k) number is K080232.

When did ZOLL E SERIES 12SL, ANALYSIS OPTION receive FDA 510(k) clearance?

ZOLL E SERIES 12SL, ANALYSIS OPTION received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080232.

Who is the listed applicant for ZOLL E SERIES 12SL, ANALYSIS OPTION?

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 E SERIES 12SL, ANALYSIS OPTION?

The FDA product code for ZOLL E SERIES 12SL, ANALYSIS OPTION 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)

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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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