The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Skyline 55, Model Ver 1.
| Device ID | K092153 |
| 510k Number | K092153 |
| Device Name: | SKYLINE 55, MODEL VER 1 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED 1051 PERIMETER DRIVE, STE 470 Schaumburg, IL 60173 |
| Contact | Shailesh Bhosale |
| Correspondent | Shailesh Bhosale LARSEN & TOUBRO LIMITED 1051 PERIMETER DRIVE, STE 470 Schaumburg, IL 60173 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-16 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18904269451537 | K092153 | 000 |
| 18904269451520 | K092153 | 000 |