FDA 510(k) Application Details - K211193

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K211193
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Bard Access Systems, Inc, (C.R. Bard, Inc.) 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Fabio De Pasquale Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2021
Decision Date	06/25/2021
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