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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K241615
Device Name Transducer Probe Cover
Applicant
Hony Medical Co., Ltd.
#12,9 Rd.,Changlong Ind.Zone,
Taishan,  CN 529222
Applicant Contact Zhu Huina
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.,
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number892.1570
Classification Product Code
ITX  
Date Received06/05/2024
Decision Date 07/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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