Oximeter To Measure Hemoglobin
FDA product code GLY · Class II (moderate risk) · 21 CFR 864.7500 · Hematology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050014 | Hemonir TMGLY · Traditional | Nir Diagnostics, Inc. | 05/05/2005SE |
| K993104 | Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova…GLY · Traditional | Nova Biomedical Corp. | 12/02/1999SE |
| K955013 | Nova Co-Oximeter AnalyzerGLY · Traditional | Nova Biomedical Corp. | 04/25/1996SE |
| K952725 | MulticheckGLY · Traditional | Radiometer America, Inc. | 02/20/1996SE |
| K895466 | Avl Model 912 Co-OxyliteGLY · Traditional | Avl Scientific Corp. | 11/06/1989SE |