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510(k) K070983

Device
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
510(k) number
K070983
Product code
PSV  
Decision
Substantially Equivalent (SESE)
Decision date
2007-07-05
Date received
2007-04-06
Regulation
892.1550
Classification name
Ultrasound Bronchoscope
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
3500 Corporate Pkwy. P.O. Box 610 Center Valley PA US 18034 18034

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
K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.2019-09-06
K021204OLYMPUS BF TYPE UM40Olympus Optical Co., Ltd.2002-05-01

Legacy Summary#

summary

FDA Review#

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