K944585 is an FDA 510(k) clearance for the SCANNING DIRECTOR. This device is classified as a System, Environmental Control, Powered (Class II - Special Controls, product code IQA).
Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on February 21, 1995, 155 days after receiving the submission on September 19, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3725.
| 510(k) Number | K944585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1994 |
| Decision Date | February 21, 1995 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IQA — System, Environmental Control, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3725 |