FDA 510(k) Application Details - K220820

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K220820
Device Name	Transducer, Tremor
Applicant	H2O Bilisim Yazilim Mustafa Kemal Mah. 2119. Sok. No 3 Bilkent Cankaya 06510 TR Other 510(k) Applications for this Company
Contact	Yagmur Selin Gulmus-Kolay Other 510(k) Applications for this Contact
Regulation Number	882.1950   More FDA Info for this Regulation Number
Classification Product Code	GYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2022
Decision Date	11/17/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review