FDA 510(k) Application Details - K150504

Device Classification Name	More FDA Info for this Device
510(K) Number	K150504
Device Name	GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Applicant	PCI MEDICAL, INC. 6 WINTER AVE. DEEP RIVER, CT 06443 US Other 510(k) Applications for this Company
Contact	Kevin Mader Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2015
Decision Date	11/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review