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FDA 510(k)

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)

K-Number: K864260 · 1987-05-11

ApplicantGrandcor Medical Systems
Decision Date1987-05-11
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Grandcor Medical Systems. It received FDA 510(k) clearance on 1987-05-11 under 510(k) number K864260. 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 APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)?

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) is a medical device that received FDA 510(k) clearance on 1987-05-11. The listed applicant is Grandcor Medical Systems. The 510(k) number is K864260.

When did APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) receive FDA 510(k) clearance?

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) received FDA 510(k) clearance on 1987-05-11, under 510(k) number K864260.

Who is the listed applicant for APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)?

The FDA 510(k) record lists Grandcor Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)?

The FDA product code for APPLICARD SYSTEM (ECG ELECTRODE SYSTEM) 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 Grandcor Medical Systems 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.

K905480SPIROSCOPEK895547GRANDCOR/CARDIOLINE ECT STRESS TESTINGK883410CARDIOMEGA-TK871890CARDIO-MEGA SYSTEMK864978APPLISCOPEK864581APPLIDYN

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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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