Clearance Summary
CATEGORY 1 CIRCULATORY SYSTEM DEVICE received FDA 510(k) clearance under submission number K840305, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-04-23.
- Submission: K840305
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1984-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.