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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K232779
Device Name QUEX ED; QUEX S
Applicant
QX World Ltd
Tinodi utca 1-3 A.ep, IV.em, 93
Budapest,  HU 1095
Applicant Contact Lilla Strobel
Correspondent
QX World Ltd
Tinodi utca 1-3 A.ep, IV.em, 93
Budapest,  HU 1095
Correspondent Contact Lilla Strobel
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GZO  
Date Received09/11/2023
Decision Date 10/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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