GALAXY 55

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 Galaxy 55.

Pre-market Notification Details

Device IDK082685
510k NumberK082685
Device Name:GALAXY 55
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant LARSEN & TOUBRO LIMITED 1051 PERIMETER DRIVE SUITE 470 Schaumburg,  IL  60173
ContactS.b. Bhosale
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-09-15
Decision Date2008-09-26
Summary:summary

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