FDA 510(k)

105MM ROLL FILM FLUOROGR. CAMERA, #105

K-Number: K810072 · 1981-02-12

Decision Date1981-02-12

Product CodeIZJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

105MM ROLL FILM FLUOROGR. CAMERA, #105 is the device name listed in this FDA 510(k) record. The listed applicant is Scientex Corp.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810072. The device is classified under product code IZJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 105MM ROLL FILM FLUOROGR. CAMERA, #105?

105MM ROLL FILM FLUOROGR. CAMERA, #105 is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Scientex Corp.. The 510(k) number is K810072.

When did 105MM ROLL FILM FLUOROGR. CAMERA, #105 receive FDA 510(k) clearance?

105MM ROLL FILM FLUOROGR. CAMERA, #105 received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810072.

Who is the listed applicant for 105MM ROLL FILM FLUOROGR. CAMERA, #105?

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

What is the FDA product code for 105MM ROLL FILM FLUOROGR. CAMERA, #105?

The FDA product code for 105MM ROLL FILM FLUOROGR. CAMERA, #105 is IZJ.

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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.