Clearance Summary
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON received FDA 510(k) clearance under submission number K792283, sponsored by Arzbaecher & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-11-21.
- Submission: K792283
- Applicant / Sponsor: Arzbaecher & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2050
- Decision date: 1979-11-21
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.