LiNA OperaScope With HDMI Cable And On-board LCD-single Unit, LiNA OperaScope With HDMI Cable And On-board LCD-6 Units, LiNA OperaScope Recording Module

Hysteroscope (and Accessories)

LiNA Medical ApS

The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Operascope With Hdmi Cable And On-board Lcd-single Unit, Lina Operascope With Hdmi Cable And On-board Lcd-6 Units, Lina Operascope Recording Module.

Pre-market Notification Details

Device IDK171113
510k NumberK171113
Device Name:LiNA OperaScope With HDMI Cable And On-board LCD-single Unit, LiNA OperaScope With HDMI Cable And On-board LCD-6 Units, LiNA OperaScope Recording Module
ClassificationHysteroscope (and Accessories)
Applicant LiNA Medical ApS Formervangen 5 Glostrup,  DK 2600
ContactNatalia Szychulska
CorrespondentJennifer Tribbett
Emergo Global Consulting, LLC 2500 Bee Cave Rd. Bldg. 1, Suite 300 Austin,  TX  78746
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-14
Decision Date2018-01-04
Summary:summary

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