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FDA 510(k)

DANTEC 13R45 BAR ELECTRODE

K-Number: K934580 · 1994-09-26

ApplicantDantec Medical, Inc.
Decision Date1994-09-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANTEC 13R45 BAR ELECTRODE 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 1994-09-26 under 510(k) number K934580. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANTEC 13R45 BAR ELECTRODE?

DANTEC 13R45 BAR ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-09-26. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K934580.

When did DANTEC 13R45 BAR ELECTRODE receive FDA 510(k) clearance?

DANTEC 13R45 BAR ELECTRODE received FDA 510(k) clearance on 1994-09-26, under 510(k) number K934580.

Who is the listed applicant for DANTEC 13R45 BAR ELECTRODE?

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 DANTEC 13R45 BAR ELECTRODE?

The FDA product code for DANTEC 13R45 BAR ELECTRODE is GXY.

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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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