510(k) K874733
K874733 is an FDA 510(k) premarket notification submitted by Tracor Northern, Inc. for the device "GUARDIAN, EEG BRAIN MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 29, 1988. The device falls under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Tracor Northern, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 29, 1988
- Date Received
- Nov 18, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Non-Normalizing Quantitative Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
- 510(k)
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.