PULSE OXIMETER, MODEL PM-50

FDA 510(k)

FDA Class 2 ·Cardiovascular

PM-7000 PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BeneVision Central Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ViewMate Multi Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH

FDA 510(k)

FDA Class 2 ·Hematology

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound

FDA 510(k)

FDA Class 2 ·Radiology

Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TE Air Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIGITAL ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

PM-9000 EXPRESS PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology