The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Bronchofibervideoscope Olympus Bf-mp190f, Single Use Biopsy Forceps Fb-433d.
Device ID | K172726 |
510k Number | K172726 |
Device Name: | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Daphney Germain-kolawole Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-11 |
Decision Date | 2018-04-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170401951 | K172726 | 000 |
04953170395581 | K172726 | 000 |
14953170394536 | K172726 | 000 |
04953170437557 | K172726 | 000 |
04953170233012 | K172726 | 000 |