The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Stellar 404 Monitoring System.
| Device ID | K042560 |
| 510k Number | K042560 |
| Device Name: | STELLAR 404 MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED 1821 WALDEN OFFICE SQUARE SUITE 400 Schaumburg, IL 60173 |
| Contact | Harry Gugnani |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-10-06 |
| Summary: | summary |