K993104 is an FDA 510(k) clearance for the STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR. This device is classified as a Oximeter To Measure Hemoglobin (Class II - Special Controls, product code GLY).
Submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on December 2, 1999, 77 days after receiving the submission on September 16, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K993104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1999 |
| Decision Date | December 02, 1999 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GLY — Oximeter To Measure Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |