The following data is part of a premarket notification filed by Eagle Technology, Inc. with the FDA for Megvision, Model Eq1000c Series.
| Device ID | K040051 |
| 510k Number | K040051 |
| Device Name: | MEGVISION, MODEL EQ1000C SERIES |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | EAGLE TECHNOLOGY, INC. 25 BISBEE COURT SUITE B Santa Fe, NM 87508 -1338 |
| Contact | Lewis Fisher |
| Correspondent | Lewis Fisher EAGLE TECHNOLOGY, INC. 25 BISBEE COURT SUITE B Santa Fe, NM 87508 -1338 |
| Product Code | OLX |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961311926266 | K040051 | 000 |