FDA Registration
Active
🇨🇳 China
Disposable SpO2 Sensors, Model: A1411-SA02C
Reg #: 3007699081
·
FEI: 3007699081
·
Expires 2025
Products
1
Proprietary Names
83
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- APK TECHNOLOGY CO., LTD
- Registration Number
- 3007699081
- FEI Number
- 3007699081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Floor, B2 Building, Industry of Hengfeng, No. 739, Zhoushi Road, Hezhou, Hangcheng Street, Baoan District, Shenzhen China
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K172981
Owner / Operator
- Firm Name
- APK Technology Co., Ltd
- Operator Number
- 10029153
- Address
- 6 Floor, B2 Building, Hengfeng Industry, Hezhou, Xixiang, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
US Agent
- Business Name
- MID-LINK International Inc.
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-06-13 |
Proprietary Names
Disposable SpO2 Sensors, Model: A1411-SA02C
Reusable SpO2 Sensors, Model:NK-SPO2 ADVT
Reusable SpO2 Sensors, Model: A1411-SP144PU
Disposable SpO2 Sensors, Model: A1411-SP01
Reusable SpO2 Sensors, Model: 10213
Reusable SpO2 Sensors, Model: A1411-SA136PV
Disposable SpO2 Sensors, Model:S533-160
Reusable SpO2 Sensors, Model: A1411-SA103PU
Reusable SpO2 Sensors, Model: A1411-SW136PU
Disposable SpO2 Sensors, Model: U5M43-16
Reusable SpO2 Sensors, Model: S805-160
Disposable SpO2 Sensors, Model: A1411-SI02C
Reusable SpO2 Sensors, Model: S410S-16L0
Disposable SpO2 Sensors, Model: A1411-SN03C
Reusable SpO2 Sensors, Model: S105S-160
Reusable SpO2 Sensors, Model: A1411-SA116PU
Disposable SpO2 Sensors, Model: A1411-SI03
Reusable SpO2 Sensors, Model: NK-TL-201T
Disposable SpO2 Sensors, Model: S523-160
Reusable SpO2 Sensors, Model: A1411-SP203PU
Disposable SpO2 Sensors, Model: A1411-SI03C
Reusable SpO2 Sensors, Model: A1411-SP116PV
Reusable SpO2 Sensors, Model: A1411-SR203PU
Disposable SpO2 Sensors, Model: A1411-SP01C
Reusable SpO2 Sensors, Model: A1411-SR103PU
Disposable SpO2 Sensors, Model: M-NK-S2S-NEO
Reusable SpO2 Sensors, Model: A1411-SA116PV
Reusable SpO2 Sensors, Model: A1411-SP103PV
Disposable SpO2 Sensors, Model: NK-TL-252T
Reusable SpO2 Sensors, Model: A1411-SP136PU
Reusable SpO2 Sensors, Model: A1411-SW203PU
Disposable SpO2 Sensors, Model: M-NK-S2S-ADT
Reusable SpO2 Sensors, Model: 10489
Disposable SpO2 Sensors, Model: PR-E600-1013P
Reusable SpO2 Sensors, Model: A1411-SA103PV
Disposable SpO2 Sensors, Model: A1411-SP03
Disposable SpO2 Sensors, Model: A1411-SA03C
Reusable SpO2 Sensors, Model: A1411-SP116PU
Reusable SpO2 Sensors, Model: A1411-SA203PV
Reusable SpO2 Sensors, Model: S105-160
Reusable SpO2 Sensors, Model: S110-360
Disposable SpO2 Sensors, Model: A1411-SA03
Disposable SpO2 Sensors, Model: A1411-SI01
Reusable SpO2 Sensors, Model: A1411-SP103PU
Disposable SpO2 Sensors, Model: A1411-SI01C
Disposable SpO2 Sensors, Model: A1411-SN01
Reusable SpO2 Sensors, Model: A1411-SR144PU
Disposable SpO2 Sensors, Model: A1411-SI02
Disposable SpO2 Sensors, Model: NK-TL-253T
Reusable SpO2 Sensors, Model: A1411-SP203PV
Disposable SpO2 Sensors, Model: A1411-SP02C
Reusable SpO2 Sensors, Model: S405S-160
Reusable SpO2 Sensors, Model: A1411-SR116PU
Disposable SpO2 Sensors, Model: S543-160
Reusable SpO2 Sensors, Model: A1411-SR136PU
S410-360
Reusable SpO2 Sensors, Model: A1411-SA136PU
Disposable SpO2 Sensors, Model: A1411-SP02
Reusable SpO2 Sensors, Model: A1411-SP144PV
Reusable SpO2 Sensors, Model: A1411-SA203PU
Disposable SpO2 Sensors, Model: S503-160
NK-TL-201T-SOFT
Disposable SpO2 Sensors, Model: A1411-SP03C
Reusable SpO2 Sensors, Model: A1411-SW103PU
Disposable SpO2 Sensors, Model: A1411-SN01C
Reusable SpO2 Sensors, Model: A1411-SA144PV
Reusable SpO2 Sensors, Model:S305-160
Reusable SpO2 Sensors, Model: A1411-SA144PU
Reusable SpO2 Sensors, Model: S905-160
Reusable SpO2 Sensors, Model: A1411-SW116PU
Reusable SpO2 Sensors, Model: S410S-360
Reusable SpO2 Sensors, Model: 10361
Disposable SpO2 Sensors, Model: A1411-SA01
Reusable SpO2 Sensors, Model: S410-1060
Disposable SpO2 Sensors, Model: A1411-SA02
Disposable SpO2 Sensors, Model: A1411-SN03
Reusable SpO2 Sensors, Model: S110S-16L0
Disposable SpO2 Sensors, Model: A1411-SA01C
Disposable SpO2 Sensors, Model: A1411-SN02C
Reusable SpO2 Sensors, Model: A1411-SP136PV
Reusable SpO2 Sensors, Model:S405-160
Disposable SpO2 Sensors, Model: A1411-SN02
Reusable SpO2 Sensors, Model: A1411-SW144PU
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device