FDA 510(k)

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

K-Number: K984582 · 1999-03-16

Decision Date1999-03-16

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Detek, Inc.. It received FDA 510(k) clearance on 1999-03-16 under 510(k) number K984582. 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 SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX?

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX is a medical device that received FDA 510(k) clearance on 1999-03-16. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K984582.

When did ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX receive FDA 510(k) clearance?

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX received FDA 510(k) clearance on 1999-03-16, under 510(k) number K984582.

Who is the listed applicant for ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX?

The FDA 510(k) record lists Bio-Detek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX?

The FDA product code for ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX is MKJ. This falls under the Dental category.

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Other records listing Bio-Detek, Inc. as applicant

K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 K071321POCKETCPR K040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR K990106ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

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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.