The following data is part of a premarket notification filed by Animas Corp. with the FDA for Model Ir 1200 Insulin Pump.
Device ID | K032257 |
510k Number | K032257 |
Device Name: | MODEL IR 1200 INSULIN PUMP |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-22 |
Decision Date | 2003-10-16 |
Summary: | summary |