Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201634
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K201634
Device Name
Accessories, Pump, Infusion
Applicant
Chengdu Shifeng Medical Technology Co., Ltd.
No. 31, Yinyuan Road
Jinhua Town, Xinjin County 611438 CN
Other 510(k) Applications for this Company
Contact
Nick Wang
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2020
Decision Date
03/26/2021
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