ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
Device Facts
| Record ID | K964515 |
|---|---|
| Device Name | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 |
| Applicant | M.C. Healthcare Products, Inc. |
| Product Code | FNL · General Hospital |
| Decision Date | Dec 31, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
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.
