CELLTRAK-B
Device Facts
| Record ID | K834585 |
|---|---|
| Device Name | CELLTRAK-B |
| Applicant | R&D Systems, Inc. |
| Product Code | FRZ · General Hospital |
| Decision Date | May 2, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6775 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.
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.
