The following data is part of a premarket notification filed by Visx, Incorporated with the FDA for Visx Customvue Slit Illuminator With Desktop Charger, Model Cv Si-1.
Device ID | K043503 |
510k Number | K043503 |
Device Name: | VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
Contact | Alan F Russell |
Correspondent | Alan F Russell VISX, INCORPORATED 3400 CENTRAL EXPRESSWAY Santa Clara, CA 95051 -0703 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-20 |
Decision Date | 2005-04-05 |
Summary: | summary |