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FDA 510(k)

DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS

K-Number: K854204 · 1986-01-10

ApplicantLa Jolla Technology, Inc.
Decision Date1986-01-10
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS is the device name listed in this FDA 510(k) record. The listed applicant is La Jolla Technology, Inc.. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K854204. 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 DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS?

DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is La Jolla Technology, Inc.. The 510(k) number is K854204.

When did DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS receive FDA 510(k) clearance?

DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS received FDA 510(k) clearance on 1986-01-10, under 510(k) number K854204.

Who is the listed applicant for DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS?

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

What is the FDA product code for DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS?

The FDA product code for DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS is GXY.

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 La Jolla Technology, 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.

K870160DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENSK864956DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.K832888ECG INTERFERENCE FILTER TF-03K830932NYNEX II

Related Devices (Code: GXY)

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Official Source

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