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FDA 510(k)

ACTIVE ELECTRODE MONITORING SYSTEM

K-Number: K000480 · 2000-05-02

ApplicantElectroscope, Inc.
Decision Date2000-05-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIVE ELECTRODE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electroscope, Inc.. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000480. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE ELECTRODE MONITORING SYSTEM?

ACTIVE ELECTRODE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Electroscope, Inc.. The 510(k) number is K000480.

When did ACTIVE ELECTRODE MONITORING SYSTEM receive FDA 510(k) clearance?

ACTIVE ELECTRODE MONITORING SYSTEM received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000480.

Who is the listed applicant for ACTIVE ELECTRODE MONITORING SYSTEM?

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

What is the FDA product code for ACTIVE ELECTRODE MONITORING SYSTEM?

The FDA product code for ACTIVE ELECTRODE MONITORING SYSTEM is GEI.

Related Clinical Trials

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Other records listing Electroscope, 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.

K972562BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLEDK973682BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,K913625ELECTROSCOPE MONITOR, EM-1K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDK912781ELECTROSHIELD

Related Devices (Code: GEI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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