meddevicedb.com FDA Device Reference

INFRASCANNER, MODEL 1000

DEN100002 Class II Post-NSE
Decision Date
2011-12-13
Sponsor / Applicant
Infrascan, Inc.

Technical Specification

510(k) Submission ID DEN100002
Product Code OPT
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 882.1935
Decision Date 2011-12-13
Clearance Pathway Post-NSE

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

INFRASCANNER, MODEL 1000 received FDA 510(k) clearance under submission number DEN100002, sponsored by Infrascan, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-12-13.

Classification & Regulation

This clearance is catalogued under FDA product code OPT and 21 CFR 882.1935, within the Ophthalmic review panel as a Class II device.