510(k) K963256
K963256 is an FDA 510(k) premarket notification submitted by Integrated Surgical Systems, S.A. for the device "NEUROMATE STEREOTACTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 1997. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Integrated Surgical Systems, S.A. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1997
- Date Received
- August 19, 1996
- 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