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FDA 510(k)

GAMMA-BSM, BETA-BSM

K-Number: K090242 · 2009-02-20

ApplicantEtex Corp.
Decision Date2009-02-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA-BSM, BETA-BSM is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K090242. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA-BSM, BETA-BSM?

GAMMA-BSM, BETA-BSM is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Etex Corp.. The 510(k) number is K090242.

When did GAMMA-BSM, BETA-BSM receive FDA 510(k) clearance?

GAMMA-BSM, BETA-BSM received FDA 510(k) clearance on 2009-02-20, under 510(k) number K090242.

Who is the listed applicant for GAMMA-BSM, BETA-BSM?

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

What is the FDA product code for GAMMA-BSM, BETA-BSM?

The FDA product code for GAMMA-BSM, BETA-BSM is MQV.

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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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