The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased And Convex Probe, Pencil And Convex Probe.
| Device ID | K140364 |
| 510k Number | K140364 |
| Device Name: | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker CHISON MEDICAL IMAGING CO., LTD. 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 | 2014-02-12 |
| Decision Date | 2014-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121406642 | K140364 | 000 |
| 06945121406635 | K140364 | 000 |
| 06945121406628 | K140364 | 000 |
| 06945121406611 | K140364 | 000 |
| 06945121406598 | K140364 | 000 |
| 06945121406581 | K140364 | 000 |
| 06945121407304 | K140364 | 000 |
| 06945121407083 | K140364 | 000 |
| 06945121406864 | K140364 | 000 |