Tangible Boost
FDA 510(k) clearance DEN200002 · decided 2020-09-24
Clearance details
- K-number
- DEN200002
- Device name
- Tangible Boost
- Applicant
- Tangible Science, Inc.
- Decision
- Unknown
- Date received
- 2020-01-13
- Decision date
- 2020-09-24
- Days to decision
- 255 days
- Clearance type
- Direct
- Product code
- QMM
- Device class
- 2
- Regulation number
- 886.5919
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.