Exo Iris

System, Imaging, Pulsed Doppler, Ultrasonic

Exo Imaging Inc.

The following data is part of a premarket notification filed by Exo Imaging Inc. with the FDA for Exo Iris.

Pre-market Notification Details

Device IDK211527
510k NumberK211527
Device Name:Exo Iris
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Exo Imaging Inc. 3600 Bridge Parkway Suite 102 Redwood City,  CA  94065
ContactAntoanela Gomard
CorrespondentAntoanela Gomard
Exo Imaging Inc. 3600 Bridge Parkway Suite 102 Redwood City,  CA  94065
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2021-08-20

Trademark Results [Exo Iris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXO IRIS
EXO IRIS
90006071 not registered Live/Pending
Exo Imaging, Inc.
2020-06-17

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