The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Gemini Pc-1,pc-2, Pc-2tx,pc-4, Signature Edition Infusion Pump (se), Medsystem Iii Infusion (msiii), Medsystem Patient C.
| Device ID | K012383 |
| 510k Number | K012383 |
| Device Name: | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C |
| 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 | 2001-07-27 |
| Decision Date | 2001-10-02 |
| Summary: | summary |