(80 days)
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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).