The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-60/dc-60s/dc-60 Exp/dc-55 Diagnostic Ultrasound Systems.
| Device ID | K152545 |
| 510k Number | K152545 |
| Device Name: | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan, 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 |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-09-08 |
| Decision Date | 2015-10-02 |
| Summary: | summary |