JAZZ Solo sensor
FDA 510(k) clearance K213637 · decided 2021-12-10
Clearance details
- K-number
- K213637
- Device name
- JAZZ Solo sensor
- Applicant
- Jazz Imaging, LLC Dba Jazz Imaging
- Decision
- Substantially Equivalent
- Date received
- 2021-11-18
- Decision date
- 2021-12-10
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.