The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Single Dose Dispensing Pin, Model 2201.
| Device ID | K013087 |
| 510k Number | K013087 |
| Device Name: | SINGLE DOSE DISPENSING PIN, MODEL 2201 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 -2733 |
| Contact | Renee L Fluet |
| Correspondent | Renee L Fluet ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego, CA 92121 -2733 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2001-11-13 |
| Summary: | summary |