GyroStim

Apparatus, Vestibular Analysis

UltraThera Technologies, Inc.

The following data is part of a premarket notification filed by Ultrathera Technologies, Inc. with the FDA for Gyrostim.

Pre-market Notification Details

Device IDK220231
510k NumberK220231
Device Name:GyroStim
ClassificationApparatus, Vestibular Analysis
Applicant UltraThera Technologies, Inc. 2 North Cascade Avenue, Suite 640 Colorado Springs,  CO  80903
ContactKevin Maher
CorrespondentKevin Maher
UltraThera Technologies, Inc. 2 North Cascade Avenue, Suite 640 Colorado Springs,  CO  80903
Product CodeLXV  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-27
Decision Date2022-04-27

Trademark Results [GyroStim]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GYROSTIM
GYROSTIM
85631016 4271971 Live/Registered
UltraThera Technologies, Inc.
2012-05-21
GYROSTIM
GYROSTIM
85631012 4271970 Live/Registered
UltraThera Technologies, Inc.
2012-05-21

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