510(k) K990683
K990683 is an FDA 510(k) premarket notification submitted by Axon Instruments, Inc. for the device "AXON MP-1 MICROPOSITIONER". The FDA issued a decision of Substantially Equivalent on November 3, 1999. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Axon Instruments, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1999
- Date Received
- March 3, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type