FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text pertains to an FDA 510(k) clearance letter for the Mallard Model 3000 Anesthesia Machine. This document is a regulatory approval and does not contain information about a study proving the device meets acceptance criteria, an AI algorithm, or any of the detailed performance metrics requested in your prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment from this document. The document primarily focuses on the device's regulatory classification, its substantial equivalence to a predicate device, and the indications for use.

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K Number

K001609

Device Name

MALLARD AIR OXYGEN ACCUBLENDER

Manufacturer

MALLARD MEDICAL, INC.

Date Cleared

2000-08-10

(78 days)

Product Code