The following data is part of a premarket notification filed by Tristan Technologies, Inc with the FDA for Model 621/624 Biomagnetometer.
| Device ID | K151135 |
| 510k Number | K151135 |
| Device Name: | MODEL 621/624 BIOMAGNETOMETER |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-29 |
| Decision Date | 2016-03-15 |
| Summary: | summary |