Clearance Summary
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 received FDA 510(k) clearance under submission number K021274, sponsored by Baxter Healthcare Corp. 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 2002-05-17.
- Submission: K021274
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2002-05-17
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.