Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K200467
Device Classification Name
More FDA Info for this Device
510(K) Number
K200467
Device Name
Control-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Michael Sarrasin
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2020
Decision Date
06/16/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact