Clearance Summary
AMG MED BRAND CLINICAL GLASS THERMOMETER received FDA 510(k) clearance under submission number K940394, sponsored by Technolab Industries (Canada) , 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 1994-05-04.
- Submission: K940394
- Applicant / Sponsor: Technolab Industries (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2920
- Decision date: 1994-05-04
Classification & Regulation
This clearance is catalogued under FDA product code FLK and 21 CFR 880.2920, within the General Hospital review panel as a Class II device.