FDA 510(k) Application Details - K200916

Device Classification Name	System, Rebreathing, Radionuclide   More FDA Info for this Device
510(K) Number	K200916
Device Name	System, Rebreathing, Radionuclide
Applicant	Cyclomedica Australia Pty Ltd Unit 4, 1 The Crescent Kingsgrove NSW 2208 AU Other 510(k) Applications for this Company
Contact	Niamh Mc Aree Other 510(k) Applications for this Contact
Regulation Number	892.1390   More FDA Info for this Regulation Number
Classification Product Code	IYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2020
Decision Date	09/01/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review