FDA 510(k)

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

Número K: K171207 · 2018-01-11

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2018-01-11

Código do produtoODG

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171207. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171207.

When did FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M receive FDA 510(k) clearance?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171207.

Who is the listed applicant for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

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

What is the FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

The FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is ODG.

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