Last synced on 12 July 2024 at 11:04 pm

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240328
510(k) Type
Special
Applicant
Signifier Medical Technologies Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/16/2024
Days to Decision
101 days
Submission Type
Summary

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240328
510(k) Type
Special
Applicant
Signifier Medical Technologies Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
5/16/2024
Days to Decision
101 days
Submission Type
Summary