K946201 is an FDA 510(k) clearance for the STAND, INFUSION. This device is classified as a Stand, Infusion (Class I — General Controls, product code FOX).
Submitted by Medical Specialties, Inc. (South Easton, US). The FDA issued a Cleared decision on April 18, 1995, 118 days after receiving the submission on December 21, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6990.
| 510(k) Number | K946201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | April 18, 1995 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOX — Stand, Infusion |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6990 |