Clearance Summary
MODEL 3200 VASCULAR MINI-LAB received FDA 510(k) clearance under submission number K944495, sponsored by Parks Medical Electronics, 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 1995-06-02.
- Submission: K944495
- Applicant / Sponsor: Parks Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1995-06-02
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.