Keeogo Dermoskeleton System

Powered Exoskeleton

B-Temia Inc.

The following data is part of a premarket notification filed by B-temia Inc. with the FDA for Keeogo Dermoskeleton System.

Pre-market Notification Details

Device IDK201539
510k NumberK201539
Device Name:Keeogo Dermoskeleton System
ClassificationPowered Exoskeleton
Applicant B-Temia Inc. 4780, Rue St-Felix-unite 105 St Augustin De Desmaure,  CA G3a 2j9
ContactAlexandre Jokic
CorrespondentKristin Davenport
Covington & Burling LLP 850 10th St NW, Washington,  DC  20001
Product CodePHL  
CFR Regulation Number890.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-09-09

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