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Tangible Boost

DEN200002 Class II Direct
Decision Date
2020-09-24
Sponsor / Applicant
Tangible Science, Inc.

Technical Specification

510(k) Submission ID DEN200002
Product Code QMM
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5919
Decision Date 2020-09-24
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Tangible Boost received FDA 510(k) clearance under submission number DEN200002, sponsored by Tangible Science, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2020-09-24.

Classification & Regulation

This clearance is catalogued under FDA product code QMM and 21 CFR 886.5919, within the Ophthalmic review panel as a Class II device.