STAR 50 MONITORING SYSTEM

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 Monitoring System.

Pre-market Notification Details

Device IDK051608
510k NumberK051608
Device Name:STAR 50 MONITORING SYSTEM
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED P.O. BOX 4341 Crofton,  MD  21114
ContactE.j. Smith
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-06-17
Decision Date2005-06-29
Summary:summary

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