510(k) K092737
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2009
- Date Received
- September 8, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Magnesium
- Device Class
- Class I
- Regulation Number
- 862.1495
- Review Panel
- CH
- Submission Type