K110535 is an FDA 510(k) clearance for the ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on March 26, 2012, 395 days after receiving the submission on February 25, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K110535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2011 |
| Decision Date | March 26, 2012 |
| Days to Decision | 395 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |