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FDA 510(k)

LIFEPATCH TM ECG ELECTRODE

K-Number: K770083 · 1977-02-01

ApplicantPhysio-Control Corp.
Decision Date1977-02-01
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFEPATCH TM ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1977-02-01 under 510(k) number K770083. 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 LIFEPATCH TM ECG ELECTRODE?

LIFEPATCH TM ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1977-02-01. The listed applicant is Physio-Control Corp.. The 510(k) number is K770083.

When did LIFEPATCH TM ECG ELECTRODE receive FDA 510(k) clearance?

LIFEPATCH TM ECG ELECTRODE received FDA 510(k) clearance on 1977-02-01, under 510(k) number K770083.

Who is the listed applicant for LIFEPATCH TM ECG ELECTRODE?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPATCH TM ECG ELECTRODE?

The FDA product code for LIFEPATCH TM ECG ELECTRODE is DRX.

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Other records listing Physio-Control Corp. 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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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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