The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Stellar 300.
| Device ID | K093017 |
| 510k Number | K093017 |
| Device Name: | STELLAR 300 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith LARSEN & TOUBRO LIMITED 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-04-29 |
| Summary: | summary |