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FDA 510(k)

ONESTEP ADULT MULTI-FUNCTION ELECTRODE

K-Number: K110742 · 2011-04-13

ApplicantZOLL Medical Corporation
Decision Date2011-04-13
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONESTEP ADULT MULTI-FUNCTION ELECTRODE 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 2011-04-13 under 510(k) number K110742. 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 ONESTEP ADULT MULTI-FUNCTION ELECTRODE?

ONESTEP ADULT MULTI-FUNCTION ELECTRODE is a medical device that received FDA 510(k) clearance on 2011-04-13. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K110742.

When did ONESTEP ADULT MULTI-FUNCTION ELECTRODE receive FDA 510(k) clearance?

ONESTEP ADULT MULTI-FUNCTION ELECTRODE received FDA 510(k) clearance on 2011-04-13, under 510(k) number K110742.

Who is the listed applicant for ONESTEP ADULT MULTI-FUNCTION ELECTRODE?

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 ONESTEP ADULT MULTI-FUNCTION ELECTRODE?

The FDA product code for ONESTEP ADULT MULTI-FUNCTION ELECTRODE is MKJ. This falls under the Dental category.

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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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