510(k) K962764
K962764 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "NEUROMAG-122". The FDA issued a decision of Substantially Equivalent on October 31, 1996. The device falls under product code OLY (Magnetoencephalograph), a Class II device regulated under 21 CFR 882.1400. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1996
- Date Received
- July 16, 1996
- 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.