FPS · Board, Bed
General Hospital · 21 CFR 880.6070 · Class 1
Overview
| Product Code | FPS |
|---|---|
| Device Name | Board, Bed |
| Regulation | 21 CFR 880.6070 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A bed board is a device intended for medical purposes that consists of a stiff board used to increase the firmness of a bed.
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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780230 | BED BOARD | Biomet, Inc. | Feb 28, 1978 | SESE |
Top Applicants
- Biomet, Inc. — 1 clearance
