Simplicit90Y

System, Image Processing, Radiological

Mirada Medical Ltd.

The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Simplicit90y.

Pre-market Notification Details

Device IDK182016
510k NumberK182016
Device Name:Simplicit90Y
ClassificationSystem, Image Processing, Radiological
Applicant Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford,  GB Ox1 1by
ContactSarah Bond
CorrespondentSarah Bond
Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford,  GB Ox1 1by
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-27
Decision Date2018-12-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B334SY2P00 K182016 000
B334SY2P20 K182016 000
B334SY2P40 K182016 000
B334SY2P60 K182016 000
B334SY2P10 K182016 000
B334SY2P120 K182016 000

Trademark Results [Simplicit90Y]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLICIT90Y
SIMPLICIT90Y
88232299 not registered Live/Pending
Biocompatibles UK Limited
2018-12-17

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