The following data is part of a premarket notification filed by Eletrocore, Llc with the FDA for Gammacore-2.
Device ID | K172270 |
510k Number | K172270 |
Device Name: | GammaCore-2 |
Classification | Non-invasive Vagus Nerve Stimulator - Headache |
Applicant | eletroCore, LLC 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
Contact | Mike Romaniw |
Correspondent | Mike Romaniw eletroCore, LLC 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 |
Product Code | PKR |
CFR Regulation Number | 882.5892 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-28 |
Decision Date | 2017-12-07 |
Summary: | summary |