FDA.reportPublic FDA data

510(k) K233119

Device
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
510(k) number
K233119
Product code
PZZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-28
Date received
2023-09-27
Regulation
864.3700
Classification name
Digital Pathology Display
Medical specialty
Pathology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Li Yafei
Address
15f, Bldg. 6, Hengda Shishang Huigu(East), Fulong Rd., Dalang Subdistrict, Longhua Shenzhen CN 518109 518109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242545RadiForce MX317W-PAEizo Corporation2025-05-23
K172922MMPC-4127F1Barco N.V.2017-12-21