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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K221179
Device Name SomnoMetry
Applicant
Neumetry Medical Inc
47102 Mission Falls Ct.
Suite 210
Fremont,  CA  94539
Applicant Contact Paul Chen
Correspondent
Neumetry Medical Inc
47102 Mission Falls Ct.
Suite 210
Fremont,  CA  94539
Correspondent Contact Paul Chen
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received04/25/2022
Decision Date 09/21/2022
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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