(90 days)
Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor, 510(k) Number K810154. 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.
Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a replacement battery (LP6/100) for medical devices.
This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for the battery. It is a regulatory approval letter stating that the device is substantially equivalent to a predicate device.
Therefore, I cannot provide the requested information based on the input text.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).