ReadeR, VieweR, QuickScan PSP
FDA 510(k) clearance K160386 · decided 2016-03-10
Clearance details
- K-number
- K160386
- Device name
- ReadeR, VieweR, QuickScan PSP
- Applicant
- Trident S.R.L
- Decision
- Substantially Equivalent
- Date received
- 2016-02-11
- Decision date
- 2016-03-10
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Assago, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.