The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley System With Medication Management System (mms).
| Device ID | K030459 |
| 510k Number | K030459 |
| Device Name: | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) |
| 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 | 2003-02-11 |
| Decision Date | 2003-04-04 |
| Summary: | summary |