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eXciteOSA with remote and eXciteOSA without remote

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200018
510(k) Type
Direct
Applicant
Signifier Medical Technologies
Country
United Kingdom
FDA Decision
Deleted
Decision Date
2/5/2021
Days to Decision
318 days

eXciteOSA with remote and eXciteOSA without remote

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200018
510(k) Type
Direct
Applicant
Signifier Medical Technologies
Country
United Kingdom
FDA Decision
Deleted
Decision Date
2/5/2021
Days to Decision
318 days