The following data is part of a premarket notification filed by Chang Gung Medical Technology Co., Ltd. with the FDA for Opus 5100 Diagnostic Doppler Ultrasound System.
| Device ID | K142982 |
| 510k Number | K142982 |
| Device Name: | OPUS 5100 Diagnostic Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Chang Gung Medical Technology Co., Ltd. 11F., No. 201-4, Dunhua North Rd. Songshan Dist Taipei City, TW 10508 |
| Contact | Cheng Ming Chen |
| Correspondent | Bob Leiker LEIKER REGULATORY & QUALITY CONSULTING 4157 North Del Rey Ave Clovis, CA 93619 |
| 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 | 2014-10-15 |
| Decision Date | 2015-09-03 |
| Summary: | summary |