The following data is part of a premarket notification filed by Ivac Medical Systems with the FDA for Ivac Medsystem Iii, Infusion Pump W/drug Editing Software Kit.
| Device ID | K961486 |
| 510k Number | K961486 |
| Device Name: | IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT |
| Classification | Accessories, Pump, Infusion |
| Applicant | IVAC MEDICAL SYSTEMS 10221 WATERIDGE CIRCLE San Diego, CA 92121 |
| Contact | Renee L Fluet |
| Correspondent | Renee L Fluet IVAC MEDICAL SYSTEMS 10221 WATERIDGE CIRCLE San Diego, CA 92121 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1998-04-17 |
| Summary: | summary |