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FDA 510(k)

SINGLE USE ACTIVE ELECTRODE HANDLE

K-Number: K780978 · 1978-06-22

ApplicantAspen Laboratories, Inc.
Decision Date1978-06-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINGLE USE ACTIVE ELECTRODE HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780978. 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 SINGLE USE ACTIVE ELECTRODE HANDLE?

SINGLE USE ACTIVE ELECTRODE HANDLE is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K780978.

When did SINGLE USE ACTIVE ELECTRODE HANDLE receive FDA 510(k) clearance?

SINGLE USE ACTIVE ELECTRODE HANDLE received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780978.

Who is the listed applicant for SINGLE USE ACTIVE ELECTRODE HANDLE?

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

What is the FDA product code for SINGLE USE ACTIVE ELECTRODE HANDLE?

The FDA product code for SINGLE USE ACTIVE ELECTRODE HANDLE 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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