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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name magnetoencephalograph
510(k) Number K191785
Device Name Orion LifeSpan MEG
Applicant
Compumedics Limited
30-40 Flockhart Street
Abbotsford,  AU 3067
Applicant Contact William Alam
Correspondent
Compumedics Limited
30-40 Flockhart Street
Abbotsford,  AU 3067
Correspondent Contact William Alam
Regulation Number882.1400
Classification Product Code
OLY  
Date Received07/03/2019
Decision Date 02/14/2020
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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