The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Xeu-m60a Endoscopic Ultrasound Center; Xgf-um180 Ultrasonic Gastrovideoscope.
| Device ID | K063683 |
| 510k Number | K063683 |
| Device Name: | OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC 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 | ODG |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2007-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368455 | K063683 | 000 |
| 04953170143670 | K063683 | 000 |
| 04953170264955 | K063683 | 000 |
| 04953170264979 | K063683 | 000 |
| 04953170264986 | K063683 | 000 |
| 04953170264993 | K063683 | 000 |
| 04953170265006 | K063683 | 000 |
| 04953170355639 | K063683 | 000 |
| 04953170356070 | K063683 | 000 |
| 04953170356087 | K063683 | 000 |
| 04953170356094 | K063683 | 000 |
| 04953170356100 | K063683 | 000 |
| 04953170356117 | K063683 | 000 |
| 04953170263255 | K063683 | 000 |