510(k) K013396
K013396 is an FDA 510(k) premarket notification submitted by Alpha Omega , Ltd. for the device "ALPHA DRIVE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2002. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Alpha Omega , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2002
- Date Received
- October 15, 2001
- Clearance Type
- Special
- 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