The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Digital Ultrasonic Diagnostic Imaging System, Model Dp-6900.
| Device ID | K090912 |
| 510k Number | K090912 |
| Device Name: | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG,KEJI 12TH RD. S. HI-TECH INDUSTRIAL PARK Nanshan, Shenzhen, Guangdong, CN 518057 |
| Contact | Tan Chuanbin |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089096 | K090912 | 000 |
| 06944904089089 | K090912 | 000 |
| 06944904034119 | K090912 | 000 |
| 06944904019758 | K090912 | 000 |
| 06944904018454 | K090912 | 000 |
| 06944904001449 | K090912 | 000 |