Clearance Summary
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER received FDA 510(k) clearance under submission number K901281, sponsored by Val-Mark Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-08-28.
- Submission: K901281
- Applicant / Sponsor: Val-Mark Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1380
- Decision date: 1991-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DRB and 21 CFR 870.1380, within the Cardiovascular review panel as a Class II device.