FDA 510(k) Application Details - K182618

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K182618
Device Name	Ventilatory Effort Recorder
Applicant	MyCardio, LLC dba SleepImage. 3513 Brighton Blvd, Suite 530 Denver, CO 80216 US Other 510(k) Applications for this Company
Contact	Robert Schueppert Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2018
Decision Date	08/14/2019
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