FDA Registration
Active
🇨🇳 China
AirFit P10 Pillow Large
Reg #: 3027344650
·
FEI: 3027344650
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZHEJIANG BARON TECHNOLOGIES CO., LTD
- Registration Number
- 3027344650
- FEI Number
- 3027344650
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FACTORY NO.3, NO.1199, XINQUN ROAD,, PINGHU CITY, ZHEJIANG. P.R.CHINA
- City
- PINGHU Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K132013
Owner / Operator
- Firm Name
- ZHEJIANG BARON TECHNOLOGIES CO., LTD
- Operator Number
- 10087807
- Address
- FACTORY NO.3, NO.1199, XINQUN ROAD,, PINGHU CITY, ZHEJIANG. P.R.CHINA
- City
- PINGHU
- State
- Zhejiang
- Postal Code
- 314200
- Country
- CN
- Correspondent
- Julia Zhu
US Agent
- Business Name
- RESMED CORP.
- Contact Name
- Cecilia Silva
- Address
- 9001 Spectrum Center Blvd, --
- City
- San Diego
- State
- CA
- ZIP
- 92123
- Country
- US
- [email protected]
- Phone
- 619 3660040
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2023-04-12 |
Proprietary Names
AirFit P10 Pillow Large
AirFit P10 Pillow X-Small
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)