Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K222132
Device Classification Name
More FDA Info for this Device
510(K) Number
K222132
Device Name
Hisense LCD monitor HMD2G21S, HMD3G21S
Applicant
Qingdao Hisense Medical Equipment Co., Ltd
No. 399 Songling Road, Laoshan District
Qingdao 266100 CN
Other 510(k) Applications for this Company
Contact
Lu Zhonghao
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2022
Decision Date
11/08/2022
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