Clearance Summary
PULSETAKER received FDA 510(k) clearance under submission number K782131, sponsored by Van, Cott, Bagley, Cornwall & Mccarth. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-01-15.
- Submission: K782131
- Applicant / Sponsor: Van, Cott, Bagley, Cornwall & Mccarth
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1979-01-15
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.