FDA Registration
Active
🇹🇼 Taiwan
PCA-C100BL AHA Patient Cable
Reg #: 3014982325
·
FEI: 3014982325
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- QT Medical, INC. Taiwan Branch
- Registration Number
- 3014982325
- FEI Number
- 3014982325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14F.-8, No. 2, Jian 8th Rd., Zhonghe Dist.
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K200722
Owner / Operator
- Firm Name
- QT MEDICAL, INC
- Operator Number
- 10058094
- Address
- 1370 Valley Vista Drive, Suite 266
- City
- Diamond Bar
- State
- CA
- Postal Code
- 91765
- Country
- US
- Correspondent
- Ying-lung Cheng
US Agent
- Business Name
- QT MEDICAL, INC
- Contact Name
- Ying-lung Cheng
- Address
- 1370 Valley Vista Drive, Suite 266
- City
- Diamond Bar
- State
- CA
- ZIP
- 91765
- Country
- US
- [email protected]
- Phone
- 424 5583500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2021-06-21 |
Proprietary Names
PCA-C100BL AHA Patient Cable
PCA-C100 AHA Patient Cable
PCA-C100BS AHA Patient Cable
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198