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The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).

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This document is a 510(k) clearance letter from the FDA for a medical device called "O2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II)". This letter primarily addresses the administrative details of the clearance: correcting a product code.

It does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document only states the "Indications For Use": "The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247)."

Therefore, I cannot provide a response that includes the requested information based on the provided text. The document is an FDA clearance letter and not a study report or clinical trial summary.

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The Oxygen Conserving Pressure Regulator (OCPR) is a demand oxygen delivery system that delivers oxygen only during inspiration. The OCPR extends and offers cost savings.

Oxygen Conserving Pressure Regulator

This document is a 510(k) clearance letter from the FDA for an "Oxygen Conserving Pressure Regulator" (OCPR). It explicitly states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, this document does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a device is at least as safe and effective as a legally marketed predicate device, often without requiring new clinical studies to prove performance against specific acceptance criteria. The clearance letter confirms "substantial equivalence" based on the information provided in the original 510(k) submission, which is not included in these excerpts.

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