Last synced on 21 June 2024 at 11:04 pm

gammaCore Sapphire

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211856
510(k) Type
Traditional
Applicant
Electrocore, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/10/2021
Days to Decision
86 days
Submission Type
Summary

gammaCore Sapphire

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211856
510(k) Type
Traditional
Applicant
Electrocore, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/10/2021
Days to Decision
86 days
Submission Type
Summary