510(k) K203639
K203639 is an FDA 510(k) premarket notification submitted by Medtronic Navigation, Inc. for the device "StealthStation Cranial Software v1.3.2". The FDA issued a decision of Substantially Equivalent on January 13, 2021. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtronic Navigation, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2021
- Date Received
- December 14, 2020
- Clearance Type
- Special
- 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