The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Eus Ultrasound Bronchofibervideoscope Olympus Bf-uc190f.
Device ID | K183525 |
510k Number | K183525 |
Device Name: | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F |
Classification | Ultrasound Bronchoscope |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Sheri Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
Product Code | PSV |
Subsequent Product Code | ITX |
Subsequent Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-19 |
Decision Date | 2019-09-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170399831 | K183525 | 000 |
04953170391378 | K183525 | 000 |