| Device Classification Name |
Magnetoencephalograph
|
| 510(k) Number |
K854466 |
| Device Name |
BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER |
| Applicant |
| Biomagnetic Technologies, Inc. |
| 9727 Pacific Heights Blvd. |
|
San Diego,
CA
92121
|
|
| Applicant Contact |
EUGENE C HIRSCHKOFF |
| Correspondent |
| Biomagnetic Technologies, Inc. |
| 9727 Pacific Heights Blvd. |
|
San Diego,
CA
92121
|
|
| Correspondent Contact |
EUGENE C HIRSCHKOFF |
| Regulation Number | 882.1400 |
| Classification Product Code |
|
| Date Received | 11/06/1985 |
| Decision Date | 02/04/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|