The following data is part of a premarket notification filed by Lumos, Inc with the FDA for Lumos, Model R 72b.
Device ID | K093596 |
510k Number | K093596 |
Device Name: | LUMOS, MODEL R 72B |
Classification | Device, Beam Limiting, X-ray, Diagnostic |
Applicant | LUMOS, INC 8726 FERRARA CT Naples, FL 34114 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm LUMOS, INC 8726 FERRARA CT Naples, FL 34114 |
Product Code | KPW |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-20 |
Decision Date | 2010-01-12 |
Summary: | summary |