K955622 is an FDA 510(k) clearance for the AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 6, 1997, 512 days after receiving the submission on December 11, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K955622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1995 |
| Decision Date | May 06, 1997 |
| Days to Decision | 512 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |