FDA 510(k) Application Details - K241211

Device Classification Name	More FDA Info for this Device
510(K) Number	K241211
Device Name	CoLumbo
Applicant	Smart Soft Healthcare 113 Gen. Kolev str, suite 7.2 Varna 9002 BG Other 510(k) Applications for this Company
Contact	Nedelcho Georgiev Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2024
Decision Date	08/15/2024
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