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FDA 510(k)

TPK CUTANEOUS ELECTRODE

K-Number: K931925 · 1993-08-16

ApplicantStaodyne, Inc.
Decision Date1993-08-16
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TPK CUTANEOUS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Staodyne, Inc.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K931925. 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 TPK CUTANEOUS ELECTRODE?

TPK CUTANEOUS ELECTRODE is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Staodyne, Inc.. The 510(k) number is K931925.

When did TPK CUTANEOUS ELECTRODE receive FDA 510(k) clearance?

TPK CUTANEOUS ELECTRODE received FDA 510(k) clearance on 1993-08-16, under 510(k) number K931925.

Who is the listed applicant for TPK CUTANEOUS ELECTRODE?

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

What is the FDA product code for TPK CUTANEOUS ELECTRODE?

The FDA product code for TPK CUTANEOUS ELECTRODE is GXY.

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Other records listing Staodyne, 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.

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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

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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