FDA 510(k) Application Details - K203839

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K203839
Device Name	Ventilatory Effort Recorder
Applicant	Itamar Medical, Ltd. 9 Halamish Street Casearea 3088900 IL Other 510(k) Applications for this Company
Contact	Efrat Litman 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	12/30/2020
Decision Date	03/21/2022
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