OLY — Magnetoencephalograph Class II
FDA product code OLY covers "Magnetoencephalograph", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLY
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191785 | compumedics limited | Orion LifeSpan MEG | February 14, 2020 |
| K152184 | tristan technologies | MagView BIOMAGNETOMETER SYSTEM | April 8, 2016 |
| K133419 | tristan technologies | BABYMEG BIOMAGNETOMETER SYSTEM | July 21, 2014 |
| K962317 | biomagnetic technologies | MAGNES 2500 WH BIOMAGNETOMETER | May 7, 1997 |
| K962764 | philips medical systems (cleveland) | NEUROMAG-122 | October 31, 1996 |
| K854466 | biomagnetic technologies | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | February 4, 1986 |