The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70xx, 71xx, 72xx, 7xxxx Series.
| Device ID | K032147 |
| 510k Number | K032147 |
| Device Name: | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES |
| Classification | Pump, Infusion |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-14 |
| Decision Date | 2003-07-25 |
| Summary: | summary |