The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Star 55.
Device ID | K080173 |
510k Number | K080173 |
Device Name: | STAR 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 |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-01-24 |
Decision Date | 2008-02-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STAR 55 76468052 not registered Dead/Abandoned |
Marciano, Anthony 2002-11-19 |
STAR 55 76468052 not registered Dead/Abandoned |
Marciano, Rebecca 2002-11-19 |