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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Invasive Vagus Nerve Stimulator - Headache
510(k) Number K211856
Device Name gammaCore Sapphire
Applicant
Electrocore, Inc.
200 Forge Way, Suite 205
Rockaway,  NJ  07866
Applicant Contact Mike Romaniw
Correspondent
Electrocore, Inc.
200 Forge Way, Suite 205
Rockaway,  NJ  07866
Correspondent Contact Mike Romaniw
Regulation Number882.5892
Classification Product Code
PKR  
Subsequent Product Code
QAK  
Date Received06/16/2021
Decision Date 09/10/2021
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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