The following data is part of a premarket notification filed by Tristan Technologies, Inc with the FDA for Magview Biomagnetometer System.
| Device ID | K152184 |
| 510k Number | K152184 |
| Device Name: | MagView BIOMAGNETOMETER SYSTEM |
| Classification | Magnetoencephalograph |
| Applicant | TRISTAN TECHNOLOGIES, INC 6191 CORNERSTONE CT., STE 107 San Diego, CA 92121 |
| Contact | Kevin Pratt |
| Correspondent | Eugene Hirschkoff EUGENE HIRSCHKOFF, CONSULTANT 3365 CALLE MARGARITA Encinitas, CA 92024 |
| Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2016-04-08 |
| Summary: | summary |