The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Eus Endoscopic Ultrasound Center Olympus Eu-me2/evis Eus Endoscopic Ultrasound Center Olympus Eu-me2 Premier Plus.
| Device ID | K203128 |
| 510k Number | K203128 |
| Device Name: | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-machi 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | ODG |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-19 |
| Decision Date | 2020-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170355677 | K203128 | 000 |
| 04953170328442 | K203128 | 000 |
| 04953170418013 | K203128 | 000 |
| 04953170418006 | K203128 | 000 |
| 04953170343490 | K203128 | 000 |
| 04953170343414 | K203128 | 000 |