SilentCloud
FDA 510(k) clearance K221125 · decided 2023-01-04
Clearance details
- K-number
- K221125
- Device name
- SilentCloud
- Applicant
- Aureliym GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-04-18
- Decision date
- 2023-01-04
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- KLW
- Device class
- 2
- Regulation number
- 874.3400
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bad Neuenahr-Ahrweiler, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.