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FDA 510(k)

TD50 ELECTROMYOGRAPH

K-Number: K935017 · 1994-07-28

ApplicantMedelec Intl. Corp.
Decision Date1994-07-28
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TD50 ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K935017. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TD50 ELECTROMYOGRAPH?

TD50 ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K935017.

When did TD50 ELECTROMYOGRAPH receive FDA 510(k) clearance?

TD50 ELECTROMYOGRAPH received FDA 510(k) clearance on 1994-07-28, under 510(k) number K935017.

Who is the listed applicant for TD50 ELECTROMYOGRAPH?

The FDA 510(k) record lists Medelec Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TD50 ELECTROMYOGRAPH?

The FDA product code for TD50 ELECTROMYOGRAPH is JXE.

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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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