FDA 510(k)

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

K-Number: K990106 · 1999-02-26

Decision Date1999-02-26

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES 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 1999-02-26 under 510(k) number K990106. 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 FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES?

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES is a medical device that received FDA 510(k) clearance on 1999-02-26. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K990106.

When did ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES receive FDA 510(k) clearance?

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES received FDA 510(k) clearance on 1999-02-26, under 510(k) number K990106.

Who is the listed applicant for ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES?

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 FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES?

The FDA product code for ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES 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 K984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

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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.