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FDA 510(k)

2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE

K-Number: K944849 · 1994-10-17

ApplicantConmed Andover Medical, Inc.
Decision Date1994-10-17
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Andover Medical, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K944849. 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 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE?

2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Conmed Andover Medical, Inc.. The 510(k) number is K944849.

When did 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE receive FDA 510(k) clearance?

2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE received FDA 510(k) clearance on 1994-10-17, under 510(k) number K944849.

Who is the listed applicant for 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE?

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

What is the FDA product code for 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE?

The FDA product code for 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE is DRX.

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Other records listing Conmed Andover Medical, 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.

K9458361800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODESK9462731700 MONITORING ECG ELECTRODEK9447261710 MONITORING ECG ELECTRODEK944655ECG ELECTRODEK942718CLOTH TENS/BNES ELECTRODEK941839DISPOSABLE SURGICAL CABLE

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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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