FDA 510(k)

FLUORO AUTOMATIC BRIGHTNESS SYS

K-Number: K812217 · 1981-09-16

Decision Date1981-09-16

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FLUORO AUTOMATIC BRIGHTNESS SYS is the device name listed in this FDA 510(k) record. The listed applicant is Keystone X-Ray, Inc.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812217. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORO AUTOMATIC BRIGHTNESS SYS?

FLUORO AUTOMATIC BRIGHTNESS SYS is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Keystone X-Ray, Inc.. The 510(k) number is K812217.

When did FLUORO AUTOMATIC BRIGHTNESS SYS receive FDA 510(k) clearance?

FLUORO AUTOMATIC BRIGHTNESS SYS received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812217.

Who is the listed applicant for FLUORO AUTOMATIC BRIGHTNESS SYS?

The FDA 510(k) record lists Keystone X-Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUORO AUTOMATIC BRIGHTNESS SYS?

The FDA product code for FLUORO AUTOMATIC BRIGHTNESS SYS is JAA.

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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.