The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Gf Type Uc180, Olympus Gf Type Uct180 Evis Exera Ii Ulatrasound Gastrovideoscope.
| Device ID | K093395 |
| 510k Number | K093395 |
| Device Name: | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 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 | NWB |
| Subsequent Product Code | ODG |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356346 | K093395 | 000 |
| 04953170356209 | K093395 | 000 |
| 04953170356216 | K093395 | 000 |
| 04953170057847 | K093395 | 000 |
| 04953170061912 | K093395 | 000 |
| 04953170071362 | K093395 | 000 |
| 04953170287879 | K093395 | 000 |
| 04953170341793 | K093395 | 000 |
| 04953170341809 | K093395 | 000 |
| 04953170355462 | K093395 | 000 |
| 04953170355479 | K093395 | 000 |
| 04953170355998 | K093395 | 000 |
| 04953170356001 | K093395 | 000 |
| 04953170356339 | K093395 | 000 |
| 04953170062063 | K093395 | 000 |