Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210670
Device Classification Name
More FDA Info for this Device
510(K) Number
K210670
Device Name
BU-CAD
Applicant
TaiHao Medical Inc.
6F.-1, No.100, Sec. 2 Heping E. Rd., Da'an Dist.
Taipei 10663 TW
Other 510(k) Applications for this Company
Contact
Hsin Hung
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/05/2021
Decision Date
12/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact