FDA 510(k) Application Details - K220256

Device Classification Name

  More FDA Info for this Device
510(K) Number K220256
Device Name MIM-Ablation
Applicant MIM Software Inc.
25800 Science Park Drive - Suite 180
Cleveland, OH 44122 US
Other 510(k) Applications for this Company
Contact Daniel Darkow
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code QTZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/31/2022
Decision Date 10/07/2022
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact