The following data is part of a premarket notification filed by Biomagnetic Technologies, Inc. with the FDA for Magnes Ii Biomagnetometer.
| Device ID | K941553 |
| 510k Number | K941553 |
| Device Name: | MAGNES II BIOMAGNETOMETER |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Contact | Eugene C Hirschkoff |
| Correspondent | Eugene C Hirschkoff BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Product Code | OLX |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1996-05-16 |
| Summary: | summary |