510(k) K063299
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2006
- Date Received
- November 1, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type