OPTEO, VIDEOGRAPH HD
FDA 510(k) clearance K133271 · decided 2014-04-28
Clearance details
- K-number
- K133271
- Device name
- OPTEO, VIDEOGRAPH HD
- Applicant
- Owandy
- Decision
- Substantially Equivalent
- Date received
- 2013-10-24
- Decision date
- 2014-04-28
- Days to decision
- 186 days
- Clearance type
- Special
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ormond Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.