The following data is part of a premarket notification filed by Tristan Technologies Inc with the FDA for Babymeg Biomagnetometer System.
| Device ID | K133419 |
| 510k Number | K133419 |
| Device Name: | BABYMEG BIOMAGNETOMETER SYSTEM |
| Classification | Magnetoencephalograph |
| Applicant | TRISTAN TECHNOLOGIES INC 3365 CALLE MARGARITA Encinitas, CA 92024 |
| Contact | Eugene Hirschkoff |
| Correspondent | Eugene Hirschkoff TRISTAN TECHNOLOGIES INC 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 | 2013-11-07 |
| Decision Date | 2014-07-21 |
| Summary: | summary |