The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M5 Diagnostic Ultrasound System.
Device ID | K083001 |
510k Number | K083001 |
Device Name: | M5 DIAGNOSTIC ULTRASOUND SYSTEM |
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, Guangdong, CN 518057 |
Contact | Tan Chuanbin |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
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 | 2008-10-08 |
Decision Date | 2008-10-22 |
Summary: | summary |