The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-8/ Dc-8 Pro/ Dc-8 Cv/ Dc-8 Exp/ Dc-8s Diagnostic Ultrasound Systems.
| Device ID | K132341 |
| 510k Number | K132341 |
| Device Name: | DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG. KEJI 12TH RD S. HI-TECH INDUSTRIAL PARK Nanshan, Shenzhen, CN 518057 |
| Contact | Zhai Pei |
| 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 | 2013-07-26 |
| Decision Date | 2013-08-15 |
| Summary: | summary |