Clearance Summary
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR received FDA 510(k) clearance under submission number K874605, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-02-02.
- Submission: K874605
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1988-02-02
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.