Last synced on 27 January 2023 at 11:04 pm

i-ED COIL System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210638
510(k) Type
Special
Applicant
Kaneka Medical America LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2021
Days to Decision
23 days
Submission Type
Summary

i-ED COIL System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210638
510(k) Type
Special
Applicant
Kaneka Medical America LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2021
Days to Decision
23 days
Submission Type
Summary