Clearance Summary
TeleRPM Gen2 Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K243060, sponsored by Guangdong Transtek Medical Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-01-30.
- Submission: K243060
- Applicant / Sponsor: Guangdong Transtek Medical Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2025-01-30
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.