The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Advantis Asc Infusion Pump And Administration Sets.
| Device ID | K993524 |
| 510k Number | K993524 |
| Device Name: | ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS |
| Classification | Pump, Infusion |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Renee L Fluet |
| Correspondent | Renee L Fluet ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. 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 | 1999-10-18 |
| Decision Date | 2000-08-01 |
| Summary: | summary |