SMART USBLITE, MODEL M011120

FDA 510(k)

FDA Class 2 ·Neurology

TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 1077 ACCUSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

TC2000 POWER UNIT AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART-SCREENER (AUDITORY)

FDA 510(k)

FDA Class 2 ·Neurology

MAXITHERM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALGO Pro Newborn Hearing Screener (ALGO Pro)

FDA 510(k)

FDA Class 2 ·Neurology

ALGO 3 NEWBORN HEARING SCREENER

FDA 510(k)

FDA Class 2 ·Neurology

Altrix Precision Temperature Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eclipse with VEMP

FDA 510(k)

FDA Class 2 ·Neurology

WARM AIR WARMING UNIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

DANTEC COUNTERPOINT MK2(TM)

FDA 510(k)

FDA Class 2 ·Neurology

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M Bair Hugger Temperature Management System (Model 675)

FDA 510(k)

FDA Class 2 ·Cardiovascular

WARMAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

THERMO-K

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular