The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Colonovideoscope Olympus Pcf-h190tl, Evis Exera Iii Colonovideoscope Olympus Pcf-h190ti, Evis Exera Iii Colonovideoscope Olympus Pcf-hq190l, Evis Exera Iii Colonovideoscope Olympus Pcf-hq190i.
| Device ID | K192793 |
| 510k Number | K192793 |
| Device Name: | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Lisa M Boyle Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170420719 | K192793 | 000 |
| 04953170420702 | K192793 | 000 |
| 04953170416132 | K192793 | 000 |
| 04953170416118 | K192793 | 000 |