The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dp-20 Digital Ultrasonic Diagnostic Imaging System; Dp-30 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K130833 |
| 510k Number | K130833 |
| Device Name: | DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089867 | K130833 | 000 |
| 06944904089638 | K130833 | 000 |
| 06944904089430 | K130833 | 000 |
| 06944904088723 | K130833 | 000 |
| 06944904087382 | K130833 | 000 |
| 06944904085593 | K130833 | 000 |
| 06944904030524 | K130833 | 000 |
| 06944904030517 | K130833 | 000 |
| 06944904000282 | K130833 | 000 |