Clearance Summary
PRIME PCA AND PCA/CONTINUOUS SYSTEMS received FDA 510(k) clearance under submission number K920637, sponsored by Prime Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-01-15.
- Submission: K920637
- Applicant / Sponsor: Prime Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1993-01-15
Classification & Regulation
This clearance is catalogued under FDA product code MEA and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.