(89 days)
Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373. 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.
Rechargeable Battery #M12/630
The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery (Alexander Manufacturing Company Rechargeable Battery #M12/630). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.
Therefore, I cannot fulfill your request for the requested information based on the provided text. The document is a regulatory approval letter for a medical device and does not detail the technical performance or validation studies of the battery itself.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).