Clearance Summary
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR received FDA 510(k) clearance under submission number K894335, sponsored by Midmark Corp.. 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 1989-09-12.
- Submission: K894335
- Applicant / Sponsor: Midmark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1989-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.