The following data is part of a premarket notification filed by Carefusion 303,inc. with the FDA for Alaris Pc Unit Module 8000 With Software Correction.
| Device ID | K110535 |
| 510k Number | K110535 |
| Device Name: | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION |
| Classification | Pump, Infusion |
| Applicant | CAREFUSION 303,INC. 10020 PACIFIC MESA BLVD San Diego, CA 92121 |
| Contact | Gabriela Muranevici |
| Correspondent | Gabriela Muranevici CAREFUSION 303,INC. 10020 PACIFIC MESA BLVD San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-25 |
| Decision Date | 2012-03-26 |
| Summary: | summary |