The following data is part of a premarket notification filed by Animas Corp. with the FDA for Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, And Serial Interface Adaptor Do.
| Device ID | K021439 |
| 510k Number | K021439 |
| Device Name: | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO |
| Classification | Pump, Infusion, Insulin |
| Applicant | ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Contact | Michael J Andrews |
| Correspondent | Michael J Andrews ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-05-29 |
| Summary: | summary |