510(k) K213431
K213431 is an FDA 510(k) premarket notification submitted by Shenzhen Witleaf Medical Electronics Co., Ltd. for the device "Handheld Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on Feb 26, 2023. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Witleaf Medical Electronics Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 26, 2023
- Date Received
- Oct 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
- 510(k)