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FDA 510(k)

SIGNA II RESTING ECG ELECTRODE

K-Number: K862655 · 1986-08-06

ApplicantKone Instruments, Inc.
Decision Date1986-08-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIGNA II RESTING ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Kone Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K862655. 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 SIGNA II RESTING ECG ELECTRODE?

SIGNA II RESTING ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Kone Instruments, Inc.. The 510(k) number is K862655.

When did SIGNA II RESTING ECG ELECTRODE receive FDA 510(k) clearance?

SIGNA II RESTING ECG ELECTRODE received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862655.

Who is the listed applicant for SIGNA II RESTING ECG ELECTRODE?

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

What is the FDA product code for SIGNA II RESTING ECG ELECTRODE?

The FDA product code for SIGNA II RESTING ECG ELECTRODE is DRX.

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Other records listing Kone Instruments, 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.

K873345'MICROLYTE 4/5'K870777PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZERK863466M700 STRESS MONITORK860767MODEL E 600 ELECTROCARDIOGRAPHK853354MEDIC 4K840200PROGRESS SELECTIVE DHEMISTRY ANALYZ

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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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