FDA.reportPublic FDA data

510(k) K233336

Device
21.3? 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
Applicant
Acula Technology Corp.
510(k) number
K233336
Product code
PGY
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-21
Date received
2023-09-29
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sheng-Sung Jian
Address
11, Aly. 21, Ln. 20, Rd. Dashing, Luchu Dist. Taoyuan TW 33862 33862

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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