(161 days)
Peripheral Nerve Block Support Tray is used for administration The egional or local anestheria to a patient
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Peripheral Nerve Block Support Tray." This letter is an approval for marketing the device and primarily focuses on its substantial equivalence to predicate devices, regulatory classifications, and general controls.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or any details typically found in a clinical study report or technical specification document.
Therefore, I cannot answer your request based on the provided input. The information you are asking for is simply not present in this regulatory clearance letter.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).