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FDA 510(k)

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES

K-Number: K853038 · 1986-01-07

ApplicantBio-Detek, Inc.
Decision Date1986-01-07
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DE12 RAPID TRACE AT-REST DIAGNOSTIC 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 1986-01-07 under 510(k) number K853038. 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 DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES?

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K853038.

When did DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES receive FDA 510(k) clearance?

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES received FDA 510(k) clearance on 1986-01-07, under 510(k) number K853038.

Who is the listed applicant for DE12 RAPID TRACE AT-REST DIAGNOSTIC 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 DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES?

The FDA product code for DE12 RAPID TRACE AT-REST DIAGNOSTIC 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

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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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