Clearance Summary
PROGUARD, RR-1, RR-2 received FDA 510(k) clearance under submission number K982832, sponsored by Emerson & Co. Srl. 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 1998-12-23.
- Submission: K982832
- Applicant / Sponsor: Emerson & Co. Srl
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1998-12-23
Classification & Regulation
This clearance is catalogued under FDA product code LZC and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.