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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
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