The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-70/dc-70t/dc-70 Pro/dc-70 Exp Diagnostic Ultrasound Systems.
| Device ID | K150204 |
| 510k Number | K150204 |
| Device Name: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK Shenzhen, CN 518057 |
| Contact | Yang Zhaohui |
| 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 | 2015-01-29 |
| Decision Date | 2015-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904090191 | K150204 | 000 |
| 06944904090184 | K150204 | 000 |
| 06944904089652 | K150204 | 000 |
| 06944904084008 | K150204 | 000 |
| 06944904053141 | K150204 | 000 |
| 06944904053127 | K150204 | 000 |
| 06944904053097 | K150204 | 000 |
| 06944904050317 | K150204 | 000 |
| 06944904049892 | K150204 | 000 |