Part 870 Subpart C—Cardiovascular Monitoring Devices
FDA submissions for Part 870 Subpart C—Cardiovascular Monitoring Devices in the Cardiovascular (CV) review panel, including product codes and regulations.
Section range: §§ 870.2050–870.2920
CFR Part: 870
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | 870.2050 | 2 | 24 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 870.2060 | 2 | 27 |
| DPW | Flowmeter, Blood, Cardiovascular | 870.2100 | 2 | 137 |
| DPT | Probe, Blood-Flow, Extravascular | 870.2120 | 2 | 48 |
| OFI | Laser Blood Flow Kit | 870.2120 | 2 | 0 |
| PPW | Adjunctive Cardiovascular Status Indicator | 870.2200 | 2 | 8 |
| QUO | Adjunctive Heart Failure Status Indicator | 870.2200 | 2 | 4 |
| QXZ | Adjunctive Epicardial Vascular Physiologic Status Indicator | 870.2200 | 2 | 1 |
| SDJ | Adjunctive Cardiac Amyloidosis Status Indicator | 870.2200 | 2 | 3 |
| QAQ | Adjunctive Predictive Cardiovascular Indicator | 870.2210 | 2 | 5 |
| QNL | Medium-Term Adjunctive Predictive Cardiovascular Indicator | 870.2210 | 2 | 5 |
| QNV | Adjunctive Hemodynamic Indicator With Decision Point | 870.2220 | 2 | 3 |
| SAR | Adjunctive Hemodynamic Indicator With Decision Point For Military Use | 870.2220 | 2 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 870.2300 | 2 | 338 |
| MSX | System, Network And Communication, Physiological Monitors | 870.2300 | 2 | 117 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 870.2300 | 2 | 304 |
| PFY | Low Patient Acuity Monitoring System | 870.2300 | 2 | 0 |
| PLB | Multivariate Vital Signs Index | 870.2300 | 2 | 8 |
| DQH | Cardiograph, Apex (Vibrocardiograph) | 870.2310 | 2 | 1 |
| DXR | Ballistocardiograph | 870.2320 | 2 | 5 |
| DXK | Echocardiograph | 870.2330 | 2 | 78 |
| DPS | Electrocardiograph | 870.2340 | 2 | 575 |
| MLC | Monitor, St Segment | 870.2340 | 2 | 2 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 870.2345 | 2 | 9 |
| DRW | Adaptor, Lead Switching, Electrocardiograph | 870.2350 | 2 | 8 |
| DRX | Electrode, Electrocardiograph | 870.2360 | 2 | 329 |
| MLN | Electrode, Electrocardiograph, Multi-Function | 870.2360 | 2 | 0 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 870.2370 | 2 | 11 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | 870.2380 | 2 | 1 |
| QXX | Coronary Artery Disease Machine Learning-Based Notification Software | 870.2380 | 2 | 1 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 870.2380 | 2 | 5 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 870.2380 | 2 | 2 |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | 870.2380 | 2 | 1 |
| SFR | Hypertension Machine Learning-Based Notification Software | 870.2380 | 2 | 1 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 870.2380 | 2 | 1 |
| DQC | Phonocardiograph | 870.2390 | 1 | 18 |
| DYC | Vectorcardiograph | 870.2400 | 2 | 4 |
| DXJ | Display, Cathode-Ray Tube, Medical | 870.2450 | 2 | 78 |
| DRJ | System, Signal Isolation | 870.2600 | 1 | 4 |
| DRI | Monitor, Line Isolation | 870.2620 | 1 | 4 |
| DSM | Alarm, Leakage Current, Portable | 870.2640 | 1 | 1 |
| DRZ | Oscillometer | 870.2675 | 2 | 0 |
| DQA | Oximeter | 870.2700 | 2 | 723 |
| MUD | Oximeter, Tissue Saturation | 870.2700 | 2 | 73 |
| NLF | Oximeter, Reprocessed | 870.2700 | 2 | 27 |
| NMD | Oximeter, Tissue Saturation, Reprocessed | 870.2700 | 2 | 2 |
| OCH | Oximeter, Infrared, Sporting, Aviation | 870.2700 | 2 | 0 |
| OLK | Pulse Oximeter For Over-The-Counter Use | 870.2700 | 2 | 2 |
| PGJ | Oximeter, Wellness | 870.2700 | 2 | 0 |
| QEM | Cerebral Oximeter | 870.2700 | 2 | 1 |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 870.2705 | 2 | 2 |
| DPZ | Oximeter, Ear | 870.2710 | 2 | 11 |
| DQB | Phlebograph, Impedance | 870.2750 | 2 | 3 |
| OFM | Phlebotomy Blood Collection Kit | 870.2750 | 2 | 0 |
| DSB | Plethysmograph, Impedance | 870.2770 | 2 | 114 |
| MNW | Analyzer, Body Composition | 870.2770 | 2 | 79 |
| OAC | Plethysmograph, Air Displacement For Body Composition Analysis | 870.2770 | 2 | 3 |
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | 870.2770 | 2 | 10 |
| OMV | Ultrasonic Body Composition Analyzer | 870.2770 | 2 | 1 |
| PUH | Analyzer, Body Composition, Exempt | 870.2770 | 2 | 0 |
| QAF | Impedance Plethysmograph, Cranial | 870.2770 | 2 | 2 |
| QJB | Adjunct Monitor, Protein Calorie Malnutrition | 870.2770 | 2 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 870.2780 | 2 | 53 |
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | 870.2785 | 2 | 10 |
| QOK | Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate | 870.2786 | 2 | 1 |
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 870.2790 | 2 | 5 |
| SDY | Loss Of Pulse Notification Software | 870.2790 | 2 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 870.2800 | 2 | 194 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 870.2800 | 2 | 32 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 870.2800 | 2 | 59 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 870.2800 | 2 | 23 |
| DSF | Recorder, Paper Chart | 870.2810 | 1 | 87 |
| JON | Transducer, Apex Cardiographic | 870.2840 | 2 | 0 |
| DRS | Transducer, Blood-Pressure, Extravascular | 870.2850 | 2 | 148 |
| NQH | Sensor, Pressure, Aneurysm, Implantable | 870.2855 | 2 | 5 |
| JOO | Transducer, Heart Sound | 870.2860 | 2 | 0 |
| DXO | Transducer, Pressure, Catheter Tip | 870.2870 | 2 | 64 |
| JOP | Transducer, Ultrasonic | 870.2880 | 2 | 72 |
| DXP | Transducer, Vessel Occlusion | 870.2890 | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 870.2900 | 2 | 105 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 870.2910 | 2 | 191 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 870.2920 | 2 | 297 |
