Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

Laparoscope, General & Plastic Surgery

FUJIFILM Corporaton

The following data is part of a premarket notification filed by Fujifilm Corporaton with the FDA for Processor Vp-7000, Light Source Bl-7000x, Image Processing Unit Ex-0.

Pre-market Notification Details

Device IDK203717
510k NumberK203717
Device Name:Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
ClassificationLaparoscope, General & Plastic Surgery
Applicant FUJIFILM Corporaton 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
Fujifilm Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeGCJ  
Subsequent Product CodeFET
Subsequent Product CodeMUD
Subsequent Product CodeNTN
Subsequent Product CodeNWB
Subsequent Product CodePEA
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2021-06-30

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