Clearance Summary
AS 191 ECG TELEMETRY MODULE received FDA 510(k) clearance under submission number K831429, sponsored by Narco Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1983-10-14.
- Submission: K831429
- Applicant / Sponsor: Narco Scientific
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1983-10-14
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.