510(k) K833522
K833522 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "NEURO SECTOR FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on May 25, 1984. The device falls under product code GXW (Echoencephalograph), a Class II device regulated under 21 CFR 882.1240. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1984
- Date Received
- September 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Echoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1240
- Review Panel
- NE
- Submission Type