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 |