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 | K101041 |
510k Number | K101041 |
Device Name: | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | Transducer, Ultrasonic, Diagnostic |
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 | Meng Xianjun |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | ITX |
Subsequent Product Code | IYN |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-04-14 |
Decision Date | 2010-04-30 |
Summary: | summary |