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FDA 510(k)

TRACE RITE SOLID GEL ECG ELECTRODES

K-Number: K964213 · 1996-11-25

ApplicantBio-Detek, Inc.
Decision Date1996-11-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRACE RITE SOLID GEL ECG 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 1996-11-25 under 510(k) number K964213. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACE RITE SOLID GEL ECG ELECTRODES?

TRACE RITE SOLID GEL ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K964213.

When did TRACE RITE SOLID GEL ECG ELECTRODES receive FDA 510(k) clearance?

TRACE RITE SOLID GEL ECG ELECTRODES received FDA 510(k) clearance on 1996-11-25, under 510(k) number K964213.

Who is the listed applicant for TRACE RITE SOLID GEL ECG 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 TRACE RITE SOLID GEL ECG ELECTRODES?

The FDA product code for TRACE RITE SOLID GEL ECG ELECTRODES is DRX.

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Other records listing Bio-Detek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325K071321POCKETCPRK040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORK984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

View all 14 devices →

Related Devices (Code: DRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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