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FDA 510(k)

SENTRY AQUEOUS GEL ECG ELECTRODES

K-Number: K934000 · 1994-08-30

ApplicantSentry Medical Products, Inc.
Decision Date1994-08-30
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTRY AQUEOUS GEL ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Sentry Medical Products, Inc.. It received FDA 510(k) clearance on 1994-08-30 under 510(k) number K934000. 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 SENTRY AQUEOUS GEL ECG ELECTRODES?

SENTRY AQUEOUS GEL ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-08-30. The listed applicant is Sentry Medical Products, Inc.. The 510(k) number is K934000.

When did SENTRY AQUEOUS GEL ECG ELECTRODES receive FDA 510(k) clearance?

SENTRY AQUEOUS GEL ECG ELECTRODES received FDA 510(k) clearance on 1994-08-30, under 510(k) number K934000.

Who is the listed applicant for SENTRY AQUEOUS GEL ECG ELECTRODES?

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

What is the FDA product code for SENTRY AQUEOUS GEL ECG ELECTRODES?

The FDA product code for SENTRY AQUEOUS GEL ECG ELECTRODES is DRX.

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Other records listing Sentry Medical Products, 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.

K962122SENTRY RADIOTRANSLUCENT ECG ELECTRODESK955636SENTRY DISPOSABLE DISPERSIVE ELECTRODEK942827SENTRY INSERTION TRAYK935098BABY BOARDK933603LEADWIREK932704PATIENT 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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