Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K240906 |
Device Name |
TE Air Diagnostic Ultrasound System |
Applicant |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Mindray Building, Keji 12th Road South, |
Hi-tech Industrial Park, Nanshan |
Shenzhen,
CN
518057
|
|
Applicant Contact |
Zhang Yuxi |
Correspondent |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Mindray Building, Keji 12th Road South, |
Hi-tech Industrial Park, Nanshan |
Shenzhen,
CN
518057
|
|
Correspondent Contact |
Tang Jing |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/02/2024 |
Decision Date | 07/23/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|