The following data is part of a premarket notification filed by Icu Medical Inc with the FDA for Willcare, Model Gw-1020.
| Device ID | K052594 |
| 510k Number | K052594 |
| Device Name: | WILLCARE, MODEL GW-1020 |
| Classification | Pump, Infusion |
| Applicant | ICU MEDICAL INC 16787 BERNARDO CENTER DRIVE SUITE A-1 San Diego, CA 92128 |
| Contact | Scott Nelson |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2006-02-10 |
| Summary: | summary |