The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dp-20 And Dp-30 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K113153 |
| 510k Number | K113153 |
| Device Name: | DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein |
| Correspondent | Susan D Goldstein SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2011-11-28 |
| Summary: | summary |