Clearance Summary
E-SAN BLUETOOTH CRADLE received FDA 510(k) clearance under submission number K052343, sponsored by E-San Limited. 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 2005-12-07.
- Submission: K052343
- Applicant / Sponsor: E-San Limited
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2005-12-07
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.