The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Dp-5 Digital Ultrasonic Diagnostic Imaging System Dp-7 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K113632 |
| 510k Number | K113632 |
| Device Name: | DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD 55 NORTHERN BLVD. SUITE 200 New York, NY 11021 |
| Contact | Susan D Goldstein |
| Correspondent | Susan D Goldstein SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD 55 NORTHERN BLVD. SUITE 200 New York, NY 11021 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904034232 | K113632 | 000 |
| 06944904034225 | K113632 | 000 |