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FDA 510(k) Application Details - K203486
Device Classification Name
More FDA Info for this Device
510(K) Number
K203486
Device Name
Otoplan
Applicant
CAScination AG
Steigerhubelstrasse 3
Bern CH-3008 CH
Other 510(k) Applications for this Company
Contact
Jean-Francois Clemence
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/27/2020
Decision Date
08/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
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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