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FDA 510(k)

BEAMER PLUS

K-Number: K953081 · 1995-10-30

ApplicantAspen Laboratories, Inc.
Decision Date1995-10-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEAMER PLUS 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 1995-10-30 under 510(k) number K953081. 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 BEAMER PLUS?

BEAMER PLUS is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K953081.

When did BEAMER PLUS receive FDA 510(k) clearance?

BEAMER PLUS received FDA 510(k) clearance on 1995-10-30, under 510(k) number K953081.

Who is the listed applicant for BEAMER PLUS?

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 BEAMER PLUS?

The FDA product code for BEAMER PLUS 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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