The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Star (lunar Series) Monitoring System.
| Device ID | K032867 |
| 510k Number | K032867 |
| Device Name: | STAR (LUNAR SERIES) MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | Neil E 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 | 2003-09-15 |
| Decision Date | 2003-11-10 |
| Summary: | summary |