Clearance Summary
PERCUGUARD received FDA 510(k) clearance under submission number K992539, sponsored by Digit-Pro. 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 2000-02-18.
- Submission: K992539
- Applicant / Sponsor: Digit-Pro
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2000-02-18
Classification & Regulation
This clearance is catalogued under FDA product code LZB and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.