(42 days)
Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462. This battery is shipped only to customers who request a replacement battery for a particular device or to customers who specifically order this battery and therefore knows the intended use is as a replacement battery.
Replacement Battery Part Number H134
This document is an FDA 510(k) clearance letter for a replacement battery, part number H134, for the Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor. It does not contain information related to acceptance criteria, study details, or performance metrics for an AI/device for diagnostic or clinical decision support purposes.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).