The following data is part of a premarket notification filed by Chang Gung Medical Technology Co., Ltd. Linkou Fac with the FDA for Opus Diagnostic Ultrasound System & Transducers.
| Device ID | K102989 |
| 510k Number | K102989 |
| Device Name: | OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2010-12-09 |
| Summary: | summary |