K944580 is an FDA 510(k) clearance for the FLEXSYS MOBILEMATE EQUIPMENT STAND. This device is classified as a Stand, Infusion (Class I - General Controls, product code FOX).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on March 17, 1995, 179 days after receiving the submission on September 19, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6990.
| 510(k) Number | K944580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1994 |
| Decision Date | March 17, 1995 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOX — Stand, Infusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6990 |