(71 days)
Replacement battery for Corometrics Medical 5169, 41B035BA01501 ECG Monitor 115, 6153A, 510(k) Number K831852. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Not Found
The provided text is a 510(k) premarket notification approval letter for a replacement battery (Part Number MS5169) for Corometrics Medical ECG Monitors. It is a regulatory document and does not contain any information about acceptance criteria for a device's performance, nor does it describe any studies proving a device meets such criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study to prove device performance based on the provided text. The document's purpose is to state that the FDA has determined the replacement battery to be "substantially equivalent" to legally marketed predicate devices.
§ 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).