Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210448
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K210448
Device Name
Electrode, Cutaneous
Applicant
Shaoxing Yingtuo Healthcare Co.,Ltd.
NO.176 Shungeng Road,Baiguan Street,Shangyu Area,
Shaoxing City,Zhejiang
Shaoxing 312300 CN
Other 510(k) Applications for this Company
Contact
Haze XU
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/16/2021
Decision Date
08/31/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact