The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-8/dc-8 Pro/dc-8 Cv/dc-8 Exp/dc-8s.
| Device ID | K150080 |
| 510k Number | K150080 |
| Device Name: | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, P.r. China, CN 518057 |
| Contact | Zhai Pei |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-01-15 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089874 | K150080 | 000 |
| 06944904087955 | K150080 | 000 |
| 06944904087948 | K150080 | 000 |
| 06944904087931 | K150080 | 000 |
| 06944904087924 | K150080 | 000 |
| 06944904087917 | K150080 | 000 |
| 06944904087900 | K150080 | 000 |
| 06944904087894 | K150080 | 000 |
| 06944904087887 | K150080 | 000 |
| 06944904087870 | K150080 | 000 |
| 06944904050324 | K150080 | 000 |
| 06944904033419 | K150080 | 000 |
| 06944904033402 | K150080 | 000 |
| 06944904088099 | K150080 | 000 |
| 06944904088105 | K150080 | 000 |
| 06944904088112 | K150080 | 000 |
| 06944904089799 | K150080 | 000 |
| 06944904089713 | K150080 | 000 |
| 06944904089614 | K150080 | 000 |
| 06944904088679 | K150080 | 000 |
| 06944904088662 | K150080 | 000 |
| 06944904088280 | K150080 | 000 |
| 06944904088273 | K150080 | 000 |
| 06944904088198 | K150080 | 000 |
| 06944904088181 | K150080 | 000 |
| 06944904088174 | K150080 | 000 |
| 06944904088167 | K150080 | 000 |
| 06944904088143 | K150080 | 000 |
| 06944904030418 | K150080 | 000 |