Clearance Summary
4600 RECORDER received FDA 510(k) clearance under submission number K780677, sponsored by G & W Applied Science Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-05-17.
- Submission: K780677
- Applicant / Sponsor: G & W Applied Science Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2810
- Decision date: 1978-05-17
Classification & Regulation
This clearance is catalogued under FDA product code DSF and 21 CFR 870.2810, within the Cardiovascular review panel as a Class I device.