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FDA 510(k)

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC

K-Number: K850132 · 1985-04-09

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1985-04-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-04-09 under 510(k) number K850132. 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 DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC?

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC is a medical device that received FDA 510(k) clearance on 1985-04-09. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K850132.

When did DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC receive FDA 510(k) clearance?

DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC received FDA 510(k) clearance on 1985-04-09, under 510(k) number K850132.

Who is the listed applicant for DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC?

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

What is the FDA product code for DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC?

The FDA product code for DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC is DRX.

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Other records listing Consolidated Medical Equipment, 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.

K854040I.V. DRESSINGK850130PRN ECG ELECTRODEK850037CLOSED WOUND DRAINK844942PLURA-GARD CHEST DRAINAGE SYSTEMK850311DISPOS. CONDUCTIVE ADHESIVE TENS PADK850131CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS

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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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