(303 days)
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.
The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve.
I am sorry, but based on the provided document, there is no information regarding the acceptance criteria, device performance, or any studies related to the LIV Medica CPR Face Mask.
The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It does not contain details about specific performance metrics, clinical studies, or acceptance criteria that would typically be found in a study report or technical documentation.
Therefore, I cannot populate the table or answer the specific questions you've asked about acceptance criteria and studies for this device based on the given text.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).