FDA 510(k) Application Details - K251133

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K251133
Device Name	Ventilator, Continuous, Facility Use
Applicant	Telesair Inc. 199 Technology Drive, Suite 110 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Don Lin Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2025
Decision Date	05/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review