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FDA 510(k)

GEREONICS BIOPOTENTIAL SKIN ELECTRODES

K-Number: K861099 · 1986-08-06

ApplicantGereonics, Inc.
Decision Date1986-08-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEREONICS BIOPOTENTIAL SKIN ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Gereonics, Inc.. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K861099. 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 GEREONICS BIOPOTENTIAL SKIN ELECTRODES?

GEREONICS BIOPOTENTIAL SKIN ELECTRODES is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Gereonics, Inc.. The 510(k) number is K861099.

When did GEREONICS BIOPOTENTIAL SKIN ELECTRODES receive FDA 510(k) clearance?

GEREONICS BIOPOTENTIAL SKIN ELECTRODES received FDA 510(k) clearance on 1986-08-06, under 510(k) number K861099.

Who is the listed applicant for GEREONICS BIOPOTENTIAL SKIN ELECTRODES?

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

What is the FDA product code for GEREONICS BIOPOTENTIAL SKIN ELECTRODES?

The FDA product code for GEREONICS BIOPOTENTIAL SKIN ELECTRODES is DRX.

Related Clinical Trials

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.

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Other records listing Gereonics, 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.

K062883GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSORK991411GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSORK983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

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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