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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Accessories, Narrow Band Spectrum
510(k) Number K222020
Device Name HD-550 Video Endoscope System
Applicant
Sonoscape Medical Corp.
Rm. 201 & 202, 12th Bldg., Shenzhen Software Park
Phase Ii 1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nansha
Shenzhen,  CN 51857
Applicant Contact Toki Wu
Correspondent
Sonoscape Medical Corp.
Rm. 201 & 202, 12th Bldg., Shenzhen Software Park
Phase Ii 1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nansha
Shenzhen,  CN 51857
Correspondent Contact Toki Wu
Regulation Number876.1500
Classification Product Code
NWB  
Subsequent Product Codes
FDF   FDS  
Date Received07/08/2022
Decision Date 09/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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