510(k) K163209
K163209 is an FDA 510(k) premarket notification submitted by Fiagon GmbH for the device "Fiagon Navigation System". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Fiagon GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2017
- Date Received
- November 15, 2016
- 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