FDA · official record DEN200018UnknowneXciteOSA with remote and eXciteOSA without remote
United StatesQNOSignifier Medical Technologies
Official record identity
- FDA application number
- DEN200018
- Decision date
- February 05, 2021
- Published decision
- Unknown
Classification
Published parties
- Applicant
- Signifier Medical Technologies
Additional source fields
- Decision code
- DENG
- Published decision
- Unknown
- Submission type
- Direct
- Received date
- 2020-03-24
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.5575
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.