The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-7 Diagnostic Ultrasound System.
| Device ID | K103583 |
| 510k Number | K103583 |
| Device Name: | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG. KEJI 12TH RD S. HI-TECH INDUSTRIAL PARK Shenzhen, Guangdong, CN 518057 |
| Contact | Zhai Pei |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2010-12-07 |
| Decision Date | 2010-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089997 | K103583 | 000 |
| 06944904087153 | K103583 | 000 |
| 06944904087115 | K103583 | 000 |
| 06944904087061 | K103583 | 000 |
| 06944904087016 | K103583 | 000 |
| 06944904087009 | K103583 | 000 |
| 06944904086958 | K103583 | 000 |
| 06944904019529 | K103583 | 000 |
| 06944904018584 | K103583 | 000 |
| 06944904001661 | K103583 | 000 |
| 06944904087177 | K103583 | 000 |
| 06944904087191 | K103583 | 000 |
| 06944904087214 | K103583 | 000 |
| 06944904089935 | K103583 | 000 |
| 06944904089928 | K103583 | 000 |
| 06944904089881 | K103583 | 000 |
| 06944904089737 | K103583 | 000 |
| 06944904089157 | K103583 | 000 |
| 06944904087320 | K103583 | 000 |
| 06944904087313 | K103583 | 000 |
| 06944904087276 | K103583 | 000 |
| 06944904087252 | K103583 | 000 |
| 06944904001470 | K103583 | 000 |