510(k) K993104
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR by
Nova Biomedical Corp.
— Product Code GLY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1999
- Date Received
- September 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter To Measure Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type