The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Galaxy 55.
| Device ID | K082685 |
| 510k Number | K082685 |
| Device Name: | GALAXY 55 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED 1051 PERIMETER DRIVE SUITE 470 Schaumburg, IL 60173 |
| Contact | S.b. Bhosale |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-09-26 |
| Summary: | summary |