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FDA 510(k)

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES

K-Number: K983689 · 1999-01-15

ApplicantMedicotest A/S
Decision Date1999-01-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest A/S. It received FDA 510(k) clearance on 1999-01-15 under 510(k) number K983689. 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 BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES?

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1999-01-15. The listed applicant is Medicotest A/S. The 510(k) number is K983689.

When did BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES receive FDA 510(k) clearance?

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES received FDA 510(k) clearance on 1999-01-15, under 510(k) number K983689.

Who is the listed applicant for BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES?

The FDA 510(k) record lists Medicotest A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES?

The FDA product code for BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES is DRX.

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Other records listing Medicotest A/S 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.

K020382BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIAK020907NEUROLINE, SUBDERMAL NEEDLE ELECTRODESK002079MULTI-FUNCTION DEFIBRILLATION ELECTRODEK001869DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLEK973529NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODESK965194MEDICOM, TENS ELECTRODES

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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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