FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Checkme O2 Pulse Oximeter
K Number: K191088
·
Decision Dec 2, 2019
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
5
Review Days
222
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Basic Information
- Device Name
- Checkme O2 Pulse Oximeter
- K Number
- K191088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Viatom Technology Co., Ltd.
- Date Received
- April 24, 2019
- Decision Date
- December 2, 2019
- 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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Other Clearances by Shenzhen Viatom Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Feb 28, 2025 | Substantially Equivalent |
| K203812 | Oxyfit Pulse Oximeter | Nov 8, 2022 | Substantially Equivalent |
| K193348 | Blood Pressure Monitor | Jun 25, 2020 | Substantially Equivalent |
| K190207 | Blood Pressure Monitor | Aug 19, 2019 | Substantially Equivalent |