The following data is part of a premarket notification filed by Icu Datasystems, Inc. with the FDA for Centra View Device Link System.
| Device ID | K033283 |
| 510k Number | K033283 |
| Device Name: | CENTRA VIEW DEVICE LINK SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ICU DATASYSTEMS, INC. 2153 SE HAWTHORNE ROAD SUITE 220 Gainesville, FL 32641 |
| Contact | Samuel W Coons |
| Correspondent | George Kreiner UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2003-10-27 |
| Summary: | summary |