510(k) K033621
K033621 is an FDA 510(k) premarket notification submitted by Northern Digital, Inc. for the device "NDI PASSIVE SPHERES". The FDA issued a decision of Substantially Equivalent on January 27, 2004. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2004
- Date Received
- November 18, 2003
- 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