Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) (MWI) (8) Oximeter (DQA) (3) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (3) MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) (MHX) (3) Thermometer, electronic, clinical (FLL) (3) Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) (NHP) (2) ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) (CBS) (2) ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) (CBR) (2) ANALYZER, GAS, OXYGEN, GASEOUS-PHASE (CCL) (2) Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) (NHO) (2) Full-montage Standard Electroencephalograph (GWQ) (2) Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) (NHQ) (2) ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) (CBQ) (2) MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) (DRT) (2) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (2) Monitor, breathing frequency (BZQ) (2) COMPUTER, BLOOD-PRESSURE (DSK) (2) Spirometer, monitoring (w/wo alarm) (BZK) (1) Index-generating electroencephalograph software (OLW) (1) Burst suppression detection software for electroencephalograph (ORT) (1) COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION (DXG) (1) COMPUTER, DIAGNOSTIC, PROGRAMMABLE (DQK) (1) COMPUTER, OXYGEN-UPTAKE (BZL) (1) DETECTOR AND ALARM, ARRHYTHMIA (DSI) (1) ELECTROCARDIOGRAPH (DPS) (1) ALARM, BLOOD-PRESSURE (DSJ) (1) MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) (CAP) (1) MONITOR, ST SEGMENT WITH ALARM (MLD) (1) Non-normalizing quantitative electroencephalograph software (OLT) (1) Oximeter, ear (DPZ) (1) PLETHYSMOGRAPH, IMPEDANCE (DSB) (1) PROBE, THERMODILUTION (KRB) (1) Reduced- montage standard electroencephalograph (OMC) (1) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (1) STIMULATOR, NERVE, PERIPHERAL, ELECTRIC (KOI) (1)