Clearance Summary
CARDIOLAB AMPLIFIER MODULE (CAM) received FDA 510(k) clearance under submission number K910307, sponsored by Prucka Engineering, 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 1991-04-12.
- Submission: K910307
- Applicant / Sponsor: Prucka Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2050
- Decision date: 1991-04-12
Classification & Regulation
This clearance is catalogued under FDA product code DRR and 21 CFR 870.2050, within the Cardiovascular review panel as a Class II device.