(29 days)
Replacement battery for Timeter 41B905FD19G1 KHM2000 Drip Watcher Monitor Insert, 510(k) Number K844556. 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 Part Number M212
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance testing, or studies conducted on the device.
The document is a 510(k) clearance letter from the FDA for a "Rechargeable Battery Part Number M212." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device and outlines general compliance requirements.
Therefore, I cannot populate the requested information.
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).