The following data is part of a premarket notification filed by Medical Illumination, Inc. with the FDA for Illuminator Vii Mini/lum Light.
Device ID | K922280 |
510k Number | K922280 |
Device Name: | ILLUMINATOR VII MINI/LUM LIGHT |
Classification | Device, Medical Examination, Ac Powered |
Applicant | MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-15 |
Decision Date | 1993-02-05 |