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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 St.
Abbotsford,  AU 3067
Applicant Contact William Alam
Correspondent
Compumedics Limited
30-40 Flockhart St.
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
Predetermined Change
Control Plan Authorized		 No
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