510(k) K191785
K191785 is an FDA 510(k) premarket notification submitted by Compumedics Limited for the device "Orion LifeSpan MEG". The FDA issued a decision of Substantially Equivalent on February 14, 2020. The device falls under product code OLY (Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Compumedics Limited has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2020
- Date Received
- July 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnetoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
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.