The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dp-50 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K111435 |
| 510k Number | K111435 |
| Device Name: | DP-50 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 | 2011-05-23 |
| Decision Date | 2011-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089645 | K111435 | 000 |
| 06944904017907 | K111435 | 000 |
| 06944904018447 | K111435 | 000 |
| 06944904030500 | K111435 | 000 |
| 06944904054100 | K111435 | 000 |
| 06944904054148 | K111435 | 000 |
| 06944904054155 | K111435 | 000 |
| 06944904054162 | K111435 | 000 |
| 06944904086507 | K111435 | 000 |
| 06944904087351 | K111435 | 000 |
| 06944904087450 | K111435 | 000 |
| 06944904088754 | K111435 | 000 |
| 06944904089072 | K111435 | 000 |
| 06944904089102 | K111435 | 000 |
| 06944904089386 | K111435 | 000 |
| 06944904089423 | K111435 | 000 |
| 06944904089454 | K111435 | 000 |
| 06944904001562 | K111435 | 000 |