Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K143369
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K143369
Device Name
Pump, Infusion
Applicant
IRADIMED CORPORATION
1025 WILLA SPRINGS DRIVE
WINTER SPRINGS, FL 32708 US
Other 510(k) Applications for this Company
Contact
FRANCIS X CASEY
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/25/2014
Decision Date
12/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact