Clearance Summary
ELECTROCARDIOGRAPHIC ECG RECORDER received FDA 510(k) clearance under submission number K781152, sponsored by Cardio-Dynamics Laboratories, 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 1978-08-31.
- Submission: K781152
- Applicant / Sponsor: Cardio-Dynamics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2640
- Decision date: 1978-08-31
Classification & Regulation
This clearance is catalogued under FDA product code DSM and 21 CFR 870.2640, within the Cardiovascular review panel as a Class I device.