eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
FDA 510(k) clearance K223446 · decided 2023-01-18
Clearance details
- K-number
- K223446
- Device name
- eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
- Applicant
- Signifier Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-15
- Decision date
- 2023-01-18
- Days to decision
- 64 days
- Clearance type
- Special
- 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 with remote and eXciteOSA without remote (DEN200018) | Signifier Medical Technologies | 2021-02-05 |
Recalls involving this device
No recalls on record reference this clearance.