510(k) K253109
K253109 is an FDA 510(k) premarket notification submitted by Shenzhen Best Electronics Co., Ltd. for the device "Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)". The FDA issued a decision of Substantially Equivalent on January 7, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Best Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2026
- Date Received
- September 24, 2025
- 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