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FDA 510(k)

DISPOSABLE MONOPLAR MEDDLE ELECTRODES

K-Number: K915741 · 1992-12-08

ApplicantDantec Medical, Inc.
Decision Date1992-12-08
Product CodeGXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MONOPLAR MEDDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1992-12-08 under 510(k) number K915741. The device is classified under product code GXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE MONOPLAR MEDDLE ELECTRODES?

DISPOSABLE MONOPLAR MEDDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 1992-12-08. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K915741.

When did DISPOSABLE MONOPLAR MEDDLE ELECTRODES receive FDA 510(k) clearance?

DISPOSABLE MONOPLAR MEDDLE ELECTRODES received FDA 510(k) clearance on 1992-12-08, under 510(k) number K915741.

Who is the listed applicant for DISPOSABLE MONOPLAR MEDDLE ELECTRODES?

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

What is the FDA product code for DISPOSABLE MONOPLAR MEDDLE ELECTRODES?

The FDA product code for DISPOSABLE MONOPLAR MEDDLE ELECTRODES is GXE.

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Other records listing Dantec Medical, 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

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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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