FDA 510(k) Application Details - K203473

Device Classification Name	Plethysmograph, Impedance   More FDA Info for this Device
510(K) Number	K203473
Device Name	Plethysmograph, Impedance
Applicant	ImpediMed Limited Unit 1, 50 Parker Court Pinkenba 4008 AU Other 510(k) Applications for this Company
Contact	Catherine Kingsford Other 510(k) Applications for this Contact
Regulation Number	870.2770   More FDA Info for this Regulation Number
Classification Product Code	DSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2020
Decision Date	04/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review