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FDA 510(k)

DISPOSABLE HAND-SWITCHING ESU PENCIL

K-Number: K925619 · 1992-12-24

ApplicantBeacon Laboratories, Inc.
Decision Date1992-12-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HAND-SWITCHING ESU PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Laboratories, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K925619. 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 DISPOSABLE HAND-SWITCHING ESU PENCIL?

DISPOSABLE HAND-SWITCHING ESU PENCIL is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Beacon Laboratories, Inc.. The 510(k) number is K925619.

When did DISPOSABLE HAND-SWITCHING ESU PENCIL receive FDA 510(k) clearance?

DISPOSABLE HAND-SWITCHING ESU PENCIL received FDA 510(k) clearance on 1992-12-24, under 510(k) number K925619.

Who is the listed applicant for DISPOSABLE HAND-SWITCHING ESU PENCIL?

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

What is the FDA product code for DISPOSABLE HAND-SWITCHING ESU PENCIL?

The FDA product code for DISPOSABLE HAND-SWITCHING ESU PENCIL 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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