STAR 50 N

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 Star 50 N.

Pre-market Notification Details

Device IDK103686
510k NumberK103686
Device Name:STAR 50 N
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 Received2010-12-17
Decision Date2011-03-15
Summary:summary

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