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FDA 510(k)

CUTANEOUS ELECTRODE

K-Number: K933802 · 1994-09-07

ApplicantCadwell Laboratories, Inc.
Decision Date1994-09-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CUTANEOUS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K933802. 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 CUTANEOUS ELECTRODE?

CUTANEOUS ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K933802.

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

CUTANEOUS ELECTRODE received FDA 510(k) clearance on 1994-09-07, under 510(k) number K933802.

Who is the listed applicant for CUTANEOUS ELECTRODE?

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

What is the FDA product code for CUTANEOUS ELECTRODE?

The FDA product code for CUTANEOUS ELECTRODE is GXY.

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Other records listing Cadwell Laboratories, Inc. as applicant

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Related Devices (Code: GXY)

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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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