Search Results

The Drager-Vapor 19.3 is a non-heated calibrated vaporizer to enrich the fresh gas flow of an anesthesia delivery system with a controlled anesthetic agent vapor. The Vapor 19.3 is indicated for use with enflurane, halothane, isoflurane, and sevoflurane. The Vapor 19.3 is not indicated for use with desflurane or in the breathing circuit of an anesthesia delivery system. Federal law restricts this device to sale by or on the order of a physician.

The Drager-Vapor 19.3 (Vapor 19.3) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents, designed in a vaporizer chamber bypass arrangement.

The provided text describes a medical device, the "Dräger-Vapor® 19.3," and its substantial equivalence to predicate devices, focusing on design differences related to mounting and interlock systems. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt regarding a study's methodology (sample size, experts, ground truth, MRMC, standalone performance, training set).

Therefore, I cannot provide a response to your request, as the necessary information is not present in the given input. The document is primarily a 510(k) summary for regulatory approval, asserting substantial equivalence rather than presenting an empirical study report.

Ask a specific question about this device