K935444 is an FDA 510(k) clearance for the OCTOSTOP(R) CHAIR (NEW MODEL. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on September 2, 1994, 294 days after receiving the submission on November 12, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K935444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1993 |
| Decision Date | September 02, 1994 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |