FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable SpO2 Sensor
K Number: K192608
·
Decision Jan 24, 2020
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- Disposable SpO2 Sensor
- K Number
- K192608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Sino-K Medical Technology Co.,Ltd
- Date Received
- September 20, 2019
- Decision Date
- January 24, 2020
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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