Clearance Summary
HEMOTHERM MODEL 400 received FDA 510(k) clearance under submission number K811742, sponsored by Cincinnati Sub-Zero. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-08-13.
- Submission: K811742
- Applicant / Sponsor: Cincinnati Sub-Zero
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 1981-08-13
Classification & Regulation
This clearance is catalogued under FDA product code DWJ and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.