The following data is part of a premarket notification filed by Cardinal Health 303, Inc. with the FDA for Alaris Pc Unit, Models 8000 And 8015.
| Device ID | K091308 |
| 510k Number | K091308 |
| Device Name: | ALARIS PC UNIT, MODELS 8000 AND 8015 |
| Classification | Pump, Infusion |
| Applicant | CARDINAL HEALTH 303, INC. 10020 PACIFIC MESA BLVD. San Diego, CA 92121 |
| Contact | Michelle J Badal |
| Correspondent | Michelle J Badal CARDINAL HEALTH 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 | 2009-05-04 |
| Decision Date | 2009-07-09 |
| Summary: | summary |