Clearance Summary
EVACU SLED received FDA 510(k) clearance under submission number K913520, sponsored by Nexus Health Care Products , Ltd.. 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 1991-12-04.
- Submission: K913520
- Applicant / Sponsor: Nexus Health Care Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6900
- Decision date: 1991-12-04
Classification & Regulation
This clearance is catalogued under FDA product code FPP and 21 CFR 880.6900, within the General Hospital review panel as a Class I device.