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, Dc-3/dc-3t Diagnostic Ultrasound System.
| Device ID | K102865 |
| 510k Number | K102865 |
| Device Name: | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2010-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904090115 | K102865 | 000 |
| 06944904008370 | K102865 | 000 |
| 06944904063478 | K102865 | 000 |
| 06944904087160 | K102865 | 000 |
| 06944904087221 | K102865 | 000 |
| 06944904088129 | K102865 | 000 |
| 06944904088686 | K102865 | 000 |
| 06944904088792 | K102865 | 000 |
| 06944904088853 | K102865 | 000 |
| 06944904088914 | K102865 | 000 |
| 06944904088976 | K102865 | 000 |
| 06944904089249 | K102865 | 000 |
| 06944904089256 | K102865 | 000 |
| 06944904089300 | K102865 | 000 |
| 06944904089508 | K102865 | 000 |
| 06944904001630 | K102865 | 000 |