The following data is part of a premarket notification filed by Biomagnetic Technologies, Inc. with the FDA for Magnes 2500 Wh Biomagnetometer.
| Device ID | K962317 |
| 510k Number | K962317 |
| Device Name: | MAGNES 2500 WH BIOMAGNETOMETER |
| Classification | Magnetoencephalograph |
| Applicant | BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Contact | Eugene C Hirschkoff, Ph.d. |
| Correspondent | Eugene C Hirschkoff, Ph.d. BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1997-05-07 |
| Summary: | summary |