The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Planet 55.
| Device ID | K071472 |
| 510k Number | K071472 |
| Device Name: | PLANET 55 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | LARSEN & TOUBRO LIMITED 1821 WALDEN OFFICE SQUARE SUITE 400 Schaumburg, IL 60173 |
| Contact | Harry P Gugnani |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-09-21 |
| Summary: | summary |