FDA 510(k) Application Details - K213519

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K213519
Device Name	Transducer, Tremor
Applicant	Rune Labs, Inc. 649 Iriving Street San Francisco, CA 94122 US Other 510(k) Applications for this Company
Contact	Brian Pepin 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	11/03/2021
Decision Date	06/10/2022
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