510(k) clearances

TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)

Megin OY · Neurology

K233985Substantially EquivalentTraditionalOLX
Open FDA's page for this record
Third party flag
N
City
Espoo
Advisory committee description
Neurology
Address 1
Keilasatama 5
Statement or summary
Summary
Product code
OLX
Zip code
02150
Applicant
Megin OY
Decision date
2024-05-15
Decision code
SESE
Country code
FI
Device name
TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)
Advisory committee
NE
Contact
Laura Vanonen
K number
K233985
Date received
2023-12-18
Review advisory committee
NE
Postal code
02150
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Medical specialty description
Neurology
Regulation number
882.1400
Device class
2
Registration number
3014137562, 3010749841, 3023707151, 3017666517, 3033708293, 3014291198, 9613619, 9680891, 2031720, 3015929663, 1650946, 9612330
FEI number
3014137562, 3010749841, 3023707151, 3033708293, 3004674371, 3014291198, 3001090553, 3002716534, 3006563303, 3015929663, 3002809369, 3002624053
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.