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FDA 510(k)

PROMONTORY STIMULATING ELECTRODE

K-Number: K895081 · 1989-11-09

ApplicantCadwell Laboratories, Inc.
Decision Date1989-11-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROMONTORY STIMULATING 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 1989-11-09 under 510(k) number K895081. 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 PROMONTORY STIMULATING ELECTRODE?

PROMONTORY STIMULATING ELECTRODE is a medical device that received FDA 510(k) clearance on 1989-11-09. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K895081.

When did PROMONTORY STIMULATING ELECTRODE receive FDA 510(k) clearance?

PROMONTORY STIMULATING ELECTRODE received FDA 510(k) clearance on 1989-11-09, under 510(k) number K895081.

Who is the listed applicant for PROMONTORY STIMULATING 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 PROMONTORY STIMULATING ELECTRODE?

The FDA product code for PROMONTORY STIMULATING ELECTRODE is GXY.

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Other records listing Cadwell Laboratories, Inc. as applicant

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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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