The following data is part of a premarket notification filed by Infinite Biomedical Technologies with the FDA for Model I-2000 Monitor.
| Device ID | K072382 |
| 510k Number | K072382 |
| Device Name: | MODEL I-2000 MONITOR |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | INFINITE BIOMEDICAL TECHNOLOGIES 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
| Contact | Manan Hathi |
| Correspondent | Manan Hathi INFINITE BIOMEDICAL TECHNOLOGIES 3600 CLIPPER MILL ROAD SUITE 410 Baltimore, MD 21211 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2008-02-15 |
| Summary: | summary |