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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K242346
Device Name Grass® MR Conditional/CT Cup Electrodes
Applicant
Natus Manufacturing Limited
IDA Business Park
Gort,  IE
Applicant Contact Sanjay Mehta
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/07/2024
Decision Date 08/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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