HD-550 Video Endoscope System

Endoscope, Accessories, Narrow Band Spectrum

Sonoscape Medical Corp.

The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for Hd-550 Video Endoscope System.

Pre-market Notification Details

Device IDK222020
510k NumberK222020
Device Name:HD-550 Video Endoscope System
ClassificationEndoscope, Accessories, Narrow Band Spectrum
Applicant Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen,  CN 51857
ContactToki Wu
CorrespondentToki Wu
Sonoscape Medical Corp. Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nansha Shenzhen,  CN 51857
Product CodeNWB  
Subsequent Product CodeFDF
Subsequent Product CodeFDS
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-08
Decision Date2022-09-08

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