FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pulse Oximeter
K Number: K220101
·
Decision Mar 8, 2023
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
10
Review Days
420
Basic Information
- Device Name
- Pulse Oximeter
- K Number
- K220101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Choice Electronic Technology Co., Ltd.
- Date Received
- January 12, 2022
- Decision Date
- March 8, 2023
- 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 Beijing Choice Electronic Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232975 | Pulse Oximeter (MD300C228) | Jun 21, 2024 | Substantially Equivalent |
| K230587 | Wrist Pulse Oximeter | Nov 30, 2023 | Substantially Equivalent |
| K230172 | Pulse Oximeter | Aug 12, 2023 | Substantially Equivalent |
| K221992 | Electronic Pulse Stimulator | Oct 21, 2022 | Substantially Equivalent |
| K211400 | Pulse Oximeter | Feb 11, 2022 | Substantially Equivalent |
| K211752 | Infrared Thermometer | Jan 21, 2022 | Substantially Equivalent |
| K211754 | Vital Signs Monitor | Nov 15, 2021 | Substantially Equivalent |
| K181503 | Fingertip Pulse Oximeter | Oct 11, 2018 | Substantially Equivalent |
| K172366 | Wrist Pulse Oximeter | Mar 16, 2018 | Substantially Equivalent |