The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Alaris System Pc Unit, Model 8001.
| Device ID | K051641 |
| 510k Number | K051641 |
| Device Name: | ALARIS SYSTEM PC UNIT, MODEL 8001 |
| Classification | Pump, Infusion |
| Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403801518 | K051641 | 000 |