The following data is part of a premarket notification filed by Biomagnetic Technologies, Inc. with the FDA for Somatosensory Stimulus System.
| Device ID | K913604 |
| 510k Number | K913604 |
| Device Name: | SOMATOSENSORY STIMULUS SYSTEM |
| Classification | Stimulator, Mechanical, Evoked Response |
| Applicant | BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Contact | Gerald S Palecki |
| Correspondent | Gerald S Palecki BIOMAGNETIC TECHNOLOGIES, INC. 9727 PACIFIC HEIGHTS BLVD. San Diego, CA 92121 -3719 |
| Product Code | GZP |
| CFR Regulation Number | 882.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-14 |
| Decision Date | 1991-12-09 |