Clearance Summary
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR received FDA 510(k) clearance under submission number K862119, sponsored by Parke-Davis Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-08-29.
- Submission: K862119
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 1986-08-29
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.