Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K180788 |
Device Name |
Gas Module 3 |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Mindray Building, Keji 12th Road South High-tech Industrial |
Park, Nanshan |
Shenzhen,
CN
518057
|
|
Applicant Contact |
Yanhong Bai |
Correspondent |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Mindray Building, Keji 12th Road South High-tech Industrial |
Park, Nanshan |
Shenzhen,
CN
518057
|
|
Correspondent Contact |
Yanhong Bai |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 03/26/2018 |
Decision Date | 10/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|