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FDA 510(k)

A.D.E. ASPEN DISPERSIVE ELECTRODE

K-Number: K792315 · 1979-11-27

ApplicantZimmer, Inc.
Decision Date1979-11-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A.D.E. ASPEN DISPERSIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K792315. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.D.E. ASPEN DISPERSIVE ELECTRODE?

A.D.E. ASPEN DISPERSIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Zimmer, Inc.. The 510(k) number is K792315.

When did A.D.E. ASPEN DISPERSIVE ELECTRODE receive FDA 510(k) clearance?

A.D.E. ASPEN DISPERSIVE ELECTRODE received FDA 510(k) clearance on 1979-11-27, under 510(k) number K792315.

Who is the listed applicant for A.D.E. ASPEN DISPERSIVE ELECTRODE?

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

What is the FDA product code for A.D.E. ASPEN DISPERSIVE ELECTRODE?

The FDA product code for A.D.E. ASPEN DISPERSIVE ELECTRODE is GEI.

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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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