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 |