K961008 is an FDA 510(k) clearance for the AUTOMIX 3+3/AS COMPOUNDER 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 October 10, 1997, 577 days after receiving the submission on March 12, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K961008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1996 |
| Decision Date | October 10, 1997 |
| Days to Decision | 577 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 |