The following data is part of a premarket notification filed by Invictus Lighting with the FDA for Aura Storm.
Device ID | K212644 |
510k Number | K212644 |
Device Name: | Aura Storm |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | Invictus Lighting 1401 Main Ave. SW Hickory, NC 28602 |
Contact | Neeraj Lal |
Correspondent | Neeraj Lal Invictus Lighting 1401 Main Ave. SW Hickory, NC 28602 |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-20 |
Decision Date | 2022-05-26 |