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FDA 510(k) Application Details - K220231
Device Classification Name
Apparatus, Vestibular Analysis
More FDA Info for this Device
510(K) Number
K220231
Device Name
Apparatus, Vestibular Analysis
Applicant
UltraThera Technologies, Inc.
2 North Cascade Avenue, Suite 640
Colorado Springs, CO 80903 US
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Contact
Kevin Maher
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2022
Decision Date
04/27/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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