FDA 510(k)

BIAD NEW DETECTOR OPTION

K-Number: K923345 · 1992-09-10

ApplicantTrionix Research Laboratory, Inc.

Decision Date1992-09-10

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIAD NEW DETECTOR OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Trionix Research Laboratory, Inc.. It received FDA 510(k) clearance on 1992-09-10 under 510(k) number K923345. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIAD NEW DETECTOR OPTION?

BIAD NEW DETECTOR OPTION is a medical device that received FDA 510(k) clearance on 1992-09-10. The listed applicant is Trionix Research Laboratory, Inc.. The 510(k) number is K923345.

When did BIAD NEW DETECTOR OPTION receive FDA 510(k) clearance?

BIAD NEW DETECTOR OPTION received FDA 510(k) clearance on 1992-09-10, under 510(k) number K923345.

Who is the listed applicant for BIAD NEW DETECTOR OPTION?

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

What is the FDA product code for BIAD NEW DETECTOR OPTION?

The FDA product code for BIAD NEW DETECTOR OPTION is KPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.