510(k) K132755
K132755 is an FDA 510(k) premarket notification submitted by Renishaw Mayfield Sarl for the device "NEUROMATE FRAMELESS GEN II". The FDA issued a decision of Substantially Equivalent on Apr 29, 2014. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Renishaw Mayfield Sarl has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 2014
- Date Received
- Sep 3, 2013
- 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)