FDA 510(k) Application Details - K233337

Device Classification Name	More FDA Info for this Device
510(K) Number	K233337
Device Name	Freespira Breathing System
Applicant	Freespira, Inc 12020 113th Ave NE, Suite 215 Kirkland, WA 98034 US Other 510(k) Applications for this Company
Contact	Thomas Simon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	04/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review