Oximeter To Measure Hemoglobin
Hematology · 21 CFR 864.7500
Recent MDR events
1 adverse event reports on file
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
35 firms currently registered for this product code
Instrumentation Laboratory Co.
Bedford, MA, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Nova Biomedical Corporation
Billerica, MA, US
Diamond Diagnostics Inc.
Budapest, HU
Nova Biomedical Corporation
WALTHAM, MA, US
Opti Medical Systems Inc.
ROSWELL, GA, US
Nova Biomedical Corporation Diabetes Products
Billerica, MA, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Nova Biomedical Corporation
Billerica, MA, US
Orsense Ltd
Tel Aviv Yafo Central, IL
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
510(k) clearances
5 clearances for this product code
- Nir Diagnostics, Inc.May 5, 2005
K050014 · HEMONIR TM
- Nova Biomedical Corp.Dec 2, 1999
K993104 · STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
- Nova Biomedical Corp.Apr 25, 1996
K955013 · NOVA CO-OXIMETER ANALYZER
- Radiometer America, Inc.Feb 20, 1996
K952725 · MULTICHECK
- Avl Scientific Corp.Nov 6, 1989
K895466 · AVL MODEL 912 CO-OXYLITE