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FDA 510(k)

ELECTRODE PLACEMENT SLEEVE

K-Number: K840591 · 1984-03-23

ApplicantBio-Stimu Trend Corp.
Decision Date1984-03-23
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRODE PLACEMENT SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Stimu Trend Corp.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840591. 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 ELECTRODE PLACEMENT SLEEVE?

ELECTRODE PLACEMENT SLEEVE is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Bio-Stimu Trend Corp.. The 510(k) number is K840591.

When did ELECTRODE PLACEMENT SLEEVE receive FDA 510(k) clearance?

ELECTRODE PLACEMENT SLEEVE received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840591.

Who is the listed applicant for ELECTRODE PLACEMENT SLEEVE?

The FDA 510(k) record lists Bio-Stimu Trend Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRODE PLACEMENT SLEEVE?

The FDA product code for ELECTRODE PLACEMENT SLEEVE is GXY.

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Other records listing Bio-Stimu Trend Corp. 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.

K842033ELECTRODE PLACEMENT ARM PART GARMENTK840592ELECTRODE PLACEMENT LUMBAR SHORTSK832634SELECTRODE SYSTEM

Related Devices (Code: GXY)

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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Official Source

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