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

Endoscopic Ultrasound System, Gastroenterology-urology

FUJIFILM Medical Systems U.S.A., Inc.

The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Ultrasonic Processor Sp-900 And Fujifilm Ultrasonic Probe Pb2020-m.

Pre-market Notification Details

Device IDK171207
510k NumberK171207
Device Name:FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M
ClassificationEndoscopic Ultrasound System, Gastroenterology-urology
Applicant FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne,  NJ  07470
ContactJeffrey Wan
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne,  NJ  07470
Product CodeODG  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-25
Decision Date2018-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410343052 K171207 000
04547410342741 K171207 000

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