The following data is part of a premarket notification filed by Infinite Biomedical Technologies, Llc with the FDA for Vigilant Eeg Monitor Model Vigilant 2.0.
Device ID | K101386 |
510k Number | K101386 |
Device Name: | VIGILANT EEG MONITOR MODEL VIGILANT 2.0 |
Classification | Full-montage Standard Electroencephalograph |
Applicant | INFINITE BIOMEDICAL TECHNOLOGIES, LLC 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
Contact | Manan Hathi |
Correspondent | Manan Hathi INFINITE BIOMEDICAL TECHNOLOGIES, LLC 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-18 |
Decision Date | 2010-07-30 |