Clearance Summary
GUARDIAN AND ANDINO MODELS received FDA 510(k) clearance under submission number K932991, sponsored by Coltemp, Inc.. 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 1994-01-28.
- Submission: K932991
- Applicant / Sponsor: Coltemp, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2920
- Decision date: 1994-01-28
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.