The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-n3/dc-n3s Diagnostic Ultrasound System.
| Device ID | K140030 |
| 510k Number | K140030 |
| Device Name: | DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BLDG. 9-13 BAIWANGXIN HIGH-TEC INDUSTRIAL PARK, XILI TOWN Shenzhen, Nahshan, CN 518108 |
| Contact | Tan Zhifeng |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904090061 | K140030 | 000 |
| 06944904088204 | K140030 | 000 |
| 06944904036779 | K140030 | 000 |
| 06944904036908 | K140030 | 000 |
| 06944904036922 | K140030 | 000 |
| 06944904049878 | K140030 | 000 |
| 06944904086514 | K140030 | 000 |
| 06944904086521 | K140030 | 000 |
| 06944904086576 | K140030 | 000 |
| 06944904087306 | K140030 | 000 |
| 06944904087436 | K140030 | 000 |
| 06944904088921 | K140030 | 000 |
| 06944904089133 | K140030 | 000 |
| 06944904089355 | K140030 | 000 |
| 06944904089683 | K140030 | 000 |
| 06944904089775 | K140030 | 000 |
| 06944904090054 | K140030 | 000 |
| 06944904088037 | K140030 | 000 |