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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K241499
Device Name 21.3” 5MP Color LCD Display UMD5-21B01
Applicant
Acula Technology Corp.
11, Alley 21, Lane 20, Rd. Dashing, Luchu Dist,
Taoyuan,  TW 33862
Applicant Contact Sheng-Sung Jian
Correspondent
Center For Measurement Standards of Industrial
Bldg. 16, 321 Kuang Fu Rd.,Sec2
Hsinchu,,  TW
Correspondent Contact Tzu-Wei Li
Regulation Number892.2050
Classification Product Code
PGY  
Date Received05/28/2024
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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