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FDA 510(k)

3M RED DOT 2560 & 2570 MONITORING ELECTRODES

K-Number: K970796 · 1997-04-09

Applicant3M Healthcare
Decision Date1997-04-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3M RED DOT 2560 & 2570 MONITORING ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K970796. 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 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

3M RED DOT 2560 & 2570 MONITORING ELECTRODES is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is 3M Healthcare. The 510(k) number is K970796.

When did 3M RED DOT 2560 & 2570 MONITORING ELECTRODES receive FDA 510(k) clearance?

3M RED DOT 2560 & 2570 MONITORING ELECTRODES received FDA 510(k) clearance on 1997-04-09, under 510(k) number K970796.

Who is the listed applicant for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

The FDA product code for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES is DRX.

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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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