510(k) K181748
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2018
- Date Received
- July 2, 2018
- Clearance Type
- Traditional
- 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