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 |