FDA 510(k) Application Details - K230657

Device Classification Name	More FDA Info for this Device
510(K) Number	K230657
Device Name	BTL-99-OC
Applicant	BTL Industries Inc. 362 Elm Street Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	David Chmel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2023
Decision Date	02/01/2024
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