510(k) K172444
K172444 is an FDA 510(k) premarket notification submitted by Medtech S.A for the device "ROSA BRAIN (v3.0.0.5)". The FDA issued a decision of Substantially Equivalent on Mar 28, 2018. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtech S.A has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 2018
- Date Received
- Aug 14, 2017
- 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)