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FDA 510(k)

C TEC SERIES 9000 E.C.G. ELECTRODE

K-Number: K831977 · 1983-09-09

ApplicantSpeywood Medical, Ltd.
Decision Date1983-09-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

C TEC SERIES 9000 E.C.G. ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Speywood Medical, Ltd.. It received FDA 510(k) clearance on 1983-09-09 under 510(k) number K831977. 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 C TEC SERIES 9000 E.C.G. ELECTRODE?

C TEC SERIES 9000 E.C.G. ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-09-09. The listed applicant is Speywood Medical, Ltd.. The 510(k) number is K831977.

When did C TEC SERIES 9000 E.C.G. ELECTRODE receive FDA 510(k) clearance?

C TEC SERIES 9000 E.C.G. ELECTRODE received FDA 510(k) clearance on 1983-09-09, under 510(k) number K831977.

Who is the listed applicant for C TEC SERIES 9000 E.C.G. ELECTRODE?

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

What is the FDA product code for C TEC SERIES 9000 E.C.G. ELECTRODE?

The FDA product code for C TEC SERIES 9000 E.C.G. ELECTRODE 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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