FNK · Bed, Hydraulic, Adjustable Hospital
General Hospital · 21 CFR 880.5110 · Class 1
Overview
| Product Code | FNK |
|---|---|
| Device Name | Bed, Hydraulic, Adjustable Hospital |
| Regulation | 21 CFR 880.5110 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944929 | OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) | Merivaara Instrumentarium Corp. | Nov 22, 1994 | SESE |
Top Applicants
- Merivaara Instrumentarium Corp. — 1 clearance
