Clearance Summary
VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR received FDA 510(k) clearance under submission number K854598, sponsored by Vickers , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-04-07.
- Submission: K854598
- Applicant / Sponsor: Vickers , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1986-04-07
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.