The following data is part of a premarket notification filed by Animas Corp. with the FDA for Animas Model Ir1250 Insulin Infusion Pump.
Device ID | K042873 |
510k Number | K042873 |
Device Name: | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP |
Classification | Pump, Infusion, Insulin |
Applicant | ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
Contact | Thomas L Parker |
Correspondent | Thomas L Parker ANIMAS CORP. 200 LAWRENCE DR. West Chester, PA 19380 |
Product Code | LZG |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-18 |
Decision Date | 2004-12-10 |
Summary: | summary |