(171 days)
AirStrip OB® is intended to be used by Obstetricians for the following purposes:
- To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone
- To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time.
- To review the current Labor and Delivery patient census list.
- Provide a request for remote consultation regarding a fetal heart tracing.
- To remotely review other standard or critical real-time numeric data from Labor and Delivery.
Not Found
This document is a 510(k) clearance letter for the AirStrip OB® device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot provide the requested information from the provided text.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).