(84 days)
For use in Pancrete, Inc. U-100 Insulin Infusion Pump (K#833983) --- 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.
M7 Replacement Battery
This document is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for their Rechargeable Battery (Model M7). It confirms substantial equivalence but does not contain any information regarding acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, not on specific performance studies or acceptance criteria for 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).