FDA 510(k)

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES

K-Number: K943698 · 1994-12-28

Decision Date1994-12-28

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Medical Corp. It received FDA 510(k) clearance on 1994-12-28 under 510(k) number K943698. 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 STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES?

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Zoll Medical Corp. The 510(k) number is K943698.

When did STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES receive FDA 510(k) clearance?

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES received FDA 510(k) clearance on 1994-12-28, under 510(k) number K943698.

Who is the listed applicant for STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES?

The FDA 510(k) record lists Zoll Medical Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES?

The FDA product code for STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES is MKJ. This falls under the Dental category.

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Other records listing Zoll Medical Corp as applicant

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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.