STELLAR 300

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

LARSEN & TOUBRO LIMITED

The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Stellar 300.

Pre-market Notification Details

Device IDK103763
510k NumberK103763
Device Name:STELLAR 300
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED 1468 HARWELL AVE. Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
LARSEN & TOUBRO LIMITED 1468 HARWELL AVE. Crofton,  MD  21114
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-03-11
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.