FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M2

Endoscopic Ultrasound System, Gastroenterology-urology

Fujifilm Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ultrasonic Processor Sp-900 And Fujifilm Ultrasonic Probe Pb2020-m2.

Pre-market Notification Details

Device IDK214089
510k NumberK214089
Device Name:FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M2
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun,  JP 258-8538
ContactRandy Vader
CorrespondentKotei Aoki
Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue Suite 300 Lexington,  MA  02421
Product CodeODG  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-28
Decision Date2022-06-03


Device IdentifiersubmissionNumberSupplement
04547410445886 K214089 000

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