PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Radiology

PM-60 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

M5 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

A8, A9 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, 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

DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900

FDA 510(k)

FDA Class 2 ·Radiology

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

VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Z6 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ZS3 Ultrasound System, z.one pro Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology