FDA Registration
Inactive
🇹🇼 Taiwan
Monitor, Breathing Frequency
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FACEHEART CORP.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,
- City
- Hsinchu City Hsinchu (City)
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K243966
Owner / Operator
- Firm Name
- FaceHeart Corp.
- Operator Number
- 10088632
- Address
- Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,
- City
- Hsinchu City
- State
- Hsinchu (City)
- Postal Code
- 300
- Country
- TW
- Correspondent
- Morris Chung
US Agent
- Business Name
- President
- Contact Name
- Jerry Chang
- Address
- 1101 Carla Dr
- City
- San Jose
- State
- CA
- ZIP
- 95120
- Country
- US
- [email protected]
- Phone
- 650 9963693
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2025-06-01 |
Proprietary Names
Monitor, Breathing Frequency
Establishment Types
Manufacture Medical Device