FDA 510(k) Application Details - K160499

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K160499
Device Name	Ventilatory Effort Recorder
Applicant	Watermark Medical 1641 Worthington Road, Suite 320 West Palm Beach, FL 33409 US Other 510(k) Applications for this Company
Contact	Frank Katarow 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	02/23/2016
Decision Date	04/24/2017
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