Clearance Summary
PARAGON 8500 CARDIO-PULMONARY BED received FDA 510(k) clearance under submission number K872924, sponsored by Surgi-Med, 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 1987-10-09.
- Submission: K872924
- Applicant / Sponsor: Surgi-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1987-10-09
Classification & Regulation
This clearance is catalogued under FDA product code FNL and 21 CFR 880.5100, within the General Hospital review panel as a Class II device.