Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K191239 |
Device Name |
Smart Peak Flow Meter |
Applicant |
Guangzhou Homesun Medical Technology Co., Ltd |
Floor 7th, TianxiangBusiness Building, |
No.28, Li Fu Road, Haizhu District |
Guangzhou,
CN
510250
|
|
Applicant Contact |
Jinqun Li |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No. 22 |
Guimiao Rd. |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Tracy Che |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 12/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|