Clearance Summary
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER received FDA 510(k) clearance under submission number K903136, sponsored by Arzco Medical Electronics, 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 1991-01-18.
- Submission: K903136
- Applicant / Sponsor: Arzco Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1991-01-18
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.