(6 days)
AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review phy patient when the clinician is not at the hospital
• To view the near real-time waveforms remotely
• To remotely review other standard or critical near real-time payafam as ather deta
• To remotely review other standard of entilour roar time patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
• Heart Rate Monitored
• Respiratory Rate
• Oxygen Saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge Pressure
• Cardiac Index
• Cardiac Output
• Cerebral Perfusion Pressure
• Urine Output
• Urine/Stool Mix Output
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
• Vasoactive Infusions
• Antiarrhythmics
• Sedation
• Paralytics
• Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coaqulation
• Alleraies
• Medications
AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
I am sorry, but the provided text ({0} to {2}) does not contain information about the acceptance criteria, specific studies, or performance metrics for the AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software.
The document is a US FDA 510(k) clearance letter, which primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also lists the "Indications for Use" for the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).