The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Alaris Medical Infusion System Administration Sets.
| Device ID | K022209 |
| 510k Number | K022209 |
| Device Name: | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Renne L Fluet |
| Correspondent | Renne L Fluet ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-08 |
| Decision Date | 2002-08-06 |
| Summary: | summary |