FDA 510(k) Application Details - K193058

Device Classification Name	Airway Monitoring System   More FDA Info for this Device
510(K) Number	K193058
Device Name	Airway Monitoring System
Applicant	SonarMed, Inc. 12220 N. Meridian St., Ste. 150 Carmel, IN 46032 US Other 510(k) Applications for this Company
Contact	Laura Lyons Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	OQU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2019
Decision Date	05/15/2020
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