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510(k) K183525

Device
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
Applicant
Olympus Medical Systems Corp.
510(k) number
K183525
Product code
PSV  
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-06
Date received
2018-12-19
Regulation
892.1550
Classification name
Ultrasound Bronchoscope
Medical specialty
Radiology
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Toshiyuki Nakajima
Address
2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PSV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070983OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEMOlympus Medical Systems Corporation2007-07-05
K021204OLYMPUS BF TYPE UM40Olympus Optical Co., Ltd.2002-05-01

Legacy Summary#

summary

FDA Review#

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