eXciteOSA with remote and eXciteOSA without remote
FDA 510(k) clearance DEN200018 · decided 2021-02-05
Clearance details
- K-number
- DEN200018
- Device name
- eXciteOSA with remote and eXciteOSA without remote
- Applicant
- Signifier Medical Technologies
- Decision
- Unknown
- Date received
- 2020-03-24
- Decision date
- 2021-02-05
- Days to decision
- 318 days
- Clearance type
- Direct
- Product code
- QNO
- Device class
- 2
- Regulation number
- 872.5575
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- London, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (K240328) | Signifier Medical Technologies, Ltd. | 2024-05-16 |
| eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) (K223446) | Signifier Medical Technologies, Ltd. | 2023-01-18 |
Recalls involving this device
No recalls on record reference this clearance.