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FDA 510(k)

TRIGEL MULTIFUNCTION ELECTRODE

K-Number: K934505 · 1994-11-22

ApplicantPhysiometrix, Inc.
Decision Date1994-11-22
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIGEL MULTIFUNCTION ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K934505. 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 TRIGEL MULTIFUNCTION ELECTRODE?

TRIGEL MULTIFUNCTION ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Physiometrix, Inc.. The 510(k) number is K934505.

When did TRIGEL MULTIFUNCTION ELECTRODE receive FDA 510(k) clearance?

TRIGEL MULTIFUNCTION ELECTRODE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K934505.

Who is the listed applicant for TRIGEL MULTIFUNCTION ELECTRODE?

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

What is the FDA product code for TRIGEL MULTIFUNCTION ELECTRODE?

The FDA product code for TRIGEL MULTIFUNCTION ELECTRODE is DRX.

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Other records listing Physiometrix, Inc. 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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