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FDA 510(k)

FIKO FO;, TJER,A; O,AGER FTO-1000

K-Number: K950610 · 1995-04-25

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date1995-04-25
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FIKO FO;, TJER,A; O,AGER FTO-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K950610. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIKO FO;, TJER,A; O,AGER FTO-1000?

FIKO FO;, TJER,A; O,AGER FTO-1000 is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K950610.

When did FIKO FO;, TJER,A; O,AGER FTO-1000 receive FDA 510(k) clearance?

FIKO FO;, TJER,A; O,AGER FTO-1000 received FDA 510(k) clearance on 1995-04-25, under 510(k) number K950610.

Who is the listed applicant for FIKO FO;, TJER,A; O,AGER FTO-1000?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIKO FO;, TJER,A; O,AGER FTO-1000?

The FDA product code for FIKO FO;, TJER,A; O,AGER FTO-1000 is LMC.

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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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