510(k) K213989
K213989 is an FDA 510(k) premarket notification submitted by Brainlab AG for the device "Cranial EM System". The FDA issued a decision of Substantially Equivalent on Sep 8, 2022. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Brainlab AG has 141 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 2022
- Date Received
- Dec 20, 2021
- 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
- 510(k)