PATIENT TROLLEY 540
Device Facts
| Record ID | K943529 |
|---|---|
| Device Name | PATIENT TROLLEY 540 |
| Applicant | Merivaara Instrumentarium Corp. |
| Product Code | FPO · General Hospital |
| Decision Date | Oct 4, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6910 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
