K891293 is an FDA 510(k) clearance for the SLS SIMULATOR (MODELS SLS-9 AND SLS-14). This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on April 20, 1989, 41 days after receiving the submission on March 10, 1989.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K891293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1989 |
| Decision Date | April 20, 1989 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KPQ — System, Simulation, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5840 |