FDA 510(k) Application Details - K193586

Device Classification Name	Continuous, Ventilator, Home Use   More FDA Info for this Device
510(K) Number	K193586
Device Name	Continuous, Ventilator, Home Use
Applicant	Breas Medical AB Foretagsvagen 1 Molnlyeke SE-453 33 SE Other 510(k) Applications for this Company
Contact	Ari Sobel Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	NOU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	01/27/2021
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