FDA 510(k) Application Details - K163696

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K163696
Device Name	Ventilatory Effort Recorder
Applicant	MyCardio, LLC dba SleepImage. 370 Interlocken Blvd. Suite 650 Broomfield, CO 80021 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	12/29/2016
Decision Date	10/13/2017
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