CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS

FDA 510(k)

FDA Class 2 ·Radiology

Hemoglobin, Chain Specific, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Hemoglobin, Chain Specific, Antigen, Antiserum, Control

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

FDA classification

FDA Class 2 ·Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt

Analyzer, Nitrogen Dioxide, Exempt

FDA classification

FDA Class 2 ·Analyzer, Nitrogen Dioxide, Exempt

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt

Drape, Surgical, Exempt

FDA classification

FDA Class 2 ·Drape, Surgical, Exempt

Wire, Guide, Catheter, Exempt

FDA classification

FDA Class 2 ·Wire, Guide, Catheter, Exempt

Biliary Catheter For Irrigation And Contrast Injection, Exempt

FDA classification

FDA Class 2 ·Biliary Catheter For Irrigation And Contrast Injection, Exempt

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

Computerized Cognitive Assessment Aid, Exempt

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid, Exempt