The following data is part of a premarket notification filed by Animas Corp. with the FDA for R1000 Series Insulin Pump.
| Device ID | K993184 |
| 510k Number | K993184 |
| Device Name: | R1000 SERIES INSULIN PUMP |
| Classification | Pump, Infusion, Insulin |
| Applicant | ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante ANIMAS CORP. 590 E. LANCASTER AVE. Frazer, PA 19355 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-23 |
| Decision Date | 2000-02-10 |
| Summary: | summary |