FDA Registration
Active
🇨🇳 China
Smart Peak Flow Meter
Reg #: 3016218294
·
FEI: 3016218294
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3016218294
- FEI Number
- 3016218294
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191239
Owner / Operator
- Firm Name
- Guangzhou Homesun Medical Technology Co., Ltd
- Operator Number
- 10062023
- Address
- Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510250
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2019-12-12 |
Proprietary Names
Smart Peak Flow Meter
SpiroLink
Establishment Types
Manufacture Medical Device