FDA 510(k) Application Details - K203128

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K203128
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Olympus Medical Systems Corp. 2951 Ishikawa-machi Hachioji-shi 192-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2020
Decision Date	11/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review