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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K230148
Device Name Vlab
Applicant
Dormotech Medical, Ltd.
Yitzhak Rabin 21
Afula,  IL 33704
Applicant Contact Abed Nassir
Correspondent
Promedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
MNR  
Date Received01/19/2023
Decision Date 10/11/2023
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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