FDA 510(k) Premarket Notification K240075: FUJIFILM Endoscope Model EB-710XT

Submission Details & Decision

Normalized public record details for 510(k) notification K240075.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K240075

Applicant / Sponsor

FUJIFILM Healthcare Americas Corporation

Device Name

FUJIFILM Endoscope Model EB-710XT

Product Code

EOQ

Decision Date

2024-02-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Special

Third Party Flag

Date Received

2024-01-10

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