510(k) K180186
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2018
- Date Received
- January 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxyhemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type