Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K200313
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K200313
Device Name
Computer, Diagnostic, Programmable
Applicant
Catheter Precision, Inc.
500 International Drive, Suite 255
Mt. Olive, NJ 07828 US
Other 510(k) Applications for this Company
Contact
Steve Adler
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2020
Decision Date
09/14/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact