The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Medley Syringe Pump Module System, Model 8110.
| Device ID | K023264 |
| 510k Number | K023264 |
| Device Name: | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 |
| 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 | 2002-09-30 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403424267 | K023264 | 000 |
| 10885403811012 | K023264 | 000 |