Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
FDA 510(k) clearance K253109 · decided 2026-01-07
Clearance details
- K-number
- K253109
- Device name
- Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
- Applicant
- Shenzhen Best Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-24
- Decision date
- 2026-01-07
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.