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FDA 510(k)

GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE

K-Number: K950489 · 1995-07-03

ApplicantGraphic Controls Corp.
Decision Date1995-07-03
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1995-07-03 under 510(k) number K950489. 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 GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE?

GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Graphic Controls Corp.. The 510(k) number is K950489.

When did GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE receive FDA 510(k) clearance?

GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE received FDA 510(k) clearance on 1995-07-03, under 510(k) number K950489.

Who is the listed applicant for GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE?

The FDA product code for GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE is DRX.

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Other records listing Graphic Controls Corp. as applicant

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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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