K243060
- 510(k) number
- K243060
- Device name
- TeleRPM Gen2 Blood Glucose Monitoring System
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd. CN
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2025-01-30
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K243060.pdf
Official FDA record: K243060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.