Clearance Summary
PACER MODEL 100 INFUSION CONTROLLER received FDA 510(k) clearance under submission number K963136, sponsored by Health Watch, 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 1997-10-10.
- Submission: K963136
- Applicant / Sponsor: Health Watch, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1997-10-10
Classification & Regulation
This clearance is catalogued under FDA product code LDR and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.