OLY · Magnetoencephalograph
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | OLY |
|---|---|
| Device Name | Magnetoencephalograph |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191785 | Orion LifeSpan MEG | Compumedics Limited | Feb 14, 2020 | SESE |
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | Apr 8, 2016 | SESE |
| K133419 | BABYMEG BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | Jul 21, 2014 | SESE |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | Biomagnetic Technologies, Inc. | May 7, 1997 | SESE |
| K962764 | NEUROMAG-122 | Philips Medical Systems (Cleveland), Inc. | Oct 31, 1996 | SESE |
| K854466 | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | Biomagnetic Technologies, Inc. | Feb 4, 1986 | SESE |
Top Applicants
- Biomagnetic Technologies, Inc. — 2 clearances
- Tristan Technologies, Inc. — 2 clearances
- Compumedics Limited — 1 clearance
- Philips Medical Systems (Cleveland), Inc. — 1 clearance
