Clearance Summary
EMERGENCY/ACCIDENT TROLLEY 550 received FDA 510(k) clearance under submission number K946101, sponsored by Hogan & Hartson. 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 1995-02-07.
- Submission: K946101
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6910
- Decision date: 1995-02-07
Classification & Regulation
This clearance is catalogued under FDA product code FPO and 21 CFR 880.6910, within the General Hospital review panel as a Class II device.