FDA 510(k) Application Details - K242485

Device Classification Name	Accessory To Continuous Ventilator (Respirator)   More FDA Info for this Device
510(K) Number	K242485
Device Name	Accessory To Continuous Ventilator (Respirator)
Applicant	Breas Medical AB Foretagsvagen 1 Molnlycke 45333 SE Other 510(k) Applications for this Company
Contact	Ivan Liljegren Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2024
Decision Date	05/20/2025
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