The following data is part of a premarket notification filed by Everest Biomedical Instruments Co. with the FDA for Snap Ii Eeg Monitor.
| Device ID | K060997 |
| 510k Number | K060997 |
| Device Name: | SNAP II EEG MONITOR |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | EVEREST BIOMEDICAL INSTRUMENTS CO. 16690 SWINGLEY RIDGE RD. SUITE 140 Chesterfield, MO 63017 |
| Contact | Randall J Krohn |
| Correspondent | Randall J Krohn EVEREST BIOMEDICAL INSTRUMENTS CO. 16690 SWINGLEY RIDGE RD. SUITE 140 Chesterfield, MO 63017 |
| Product Code | OLW |
| Subsequent Product Code | GXY |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-06-15 |
| Summary: | summary |