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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K240289
Device Name Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
Applicant
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Wu Ruqin
Correspondent
Scivita Medical Technology Co., Ltd.
#2, Qingqiu St., Suzhou Industrial Park
Suzhou,  CN 215000
Correspondent Contact Dan Jiang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/01/2024
Decision Date 10/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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