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FDA 510(k)

ELECTROSCOPE MONITOR, EM-1

K-Number: K913625 · 1991-12-30

ApplicantElectroscope, Inc.
Decision Date1991-12-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSCOPE MONITOR, EM-1 is the device name listed in this FDA 510(k) record. The listed applicant is Electroscope, Inc.. It received FDA 510(k) clearance on 1991-12-30 under 510(k) number K913625. 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 ELECTROSCOPE MONITOR, EM-1?

ELECTROSCOPE MONITOR, EM-1 is a medical device that received FDA 510(k) clearance on 1991-12-30. The listed applicant is Electroscope, Inc.. The 510(k) number is K913625.

When did ELECTROSCOPE MONITOR, EM-1 receive FDA 510(k) clearance?

ELECTROSCOPE MONITOR, EM-1 received FDA 510(k) clearance on 1991-12-30, under 510(k) number K913625.

Who is the listed applicant for ELECTROSCOPE MONITOR, EM-1?

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 ELECTROSCOPE MONITOR, EM-1?

The FDA product code for ELECTROSCOPE MONITOR, EM-1 is GEI.

Related Clinical Trials

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.

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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.

K000480ACTIVE ELECTRODE MONITORING SYSTEMK972562BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLEDK973682BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDK912781ELECTROSHIELD

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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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