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PEDIATRIC VISION SCANNER

DEN130051 Class II Direct
Decision Date
2016-06-08
Sponsor / Applicant
Rebiscan, Inc.

Technical Specification

510(k) Submission ID DEN130051
Product Code PMW
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.1342
Decision Date 2016-06-08
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

PEDIATRIC VISION SCANNER received FDA 510(k) clearance under submission number DEN130051, sponsored by Rebiscan, 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 2016-06-08.

Classification & Regulation

This clearance is catalogued under FDA product code PMW and 21 CFR 886.1342, within the Ophthalmic review panel as a Class II device.