The following data is part of a premarket notification filed by Beam Technologies, Llc with the FDA for Beam Brush/beam App.
Device ID | K121165 |
510k Number | K121165 |
Device Name: | BEAM BRUSH/BEAM APP |
Classification | Toothbrush, Manual |
Applicant | BEAM TECHNOLOGIES, LLC P.O. BOX 17541 Louisville, KY 40217 |
Contact | Alex Curry |
Correspondent | Alex Curry BEAM TECHNOLOGIES, LLC P.O. BOX 17541 Louisville, KY 40217 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-17 |
Decision Date | 2012-06-21 |
Summary: | summary |