Clearance Summary
MODEL ECG100 SIMULATOR received FDA 510(k) clearance under submission number K897029, sponsored by Dynatech/Nevada, 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 1990-04-26.
- Submission: K897029
- Applicant / Sponsor: Dynatech/Nevada, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1990-04-26
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.