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United States FDA 510(k) clearance K233779Substantially Equivalent

LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)

United StatesClass 2MacroLux Medical Technology Co., Ltd.Cleared Apr 05, 2024
Verified
Clearance details
K-Number
K233779
View FDA 510(k) Summary PDF View on FDA Database
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Product Code
EOQ
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
874.4680
View CFR Regulation
Applicant information
Applicant
MacroLux Medical Technology Co., Ltd.
Contact
Linbin Ye
Location
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen 518107
CN
Medical classification
Medical Specialty
Ear, Nose, Throat
Advisory Committee
EN
Dates and decision
Date Received
Nov 27, 2023
Decision Date
Apr 05, 2024
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K233779 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Apr 05, 2024.

This page provides complete clearance details including product code EOQ, medical specialty classification (Ear, Nose, Throat), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.