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K Number
K132168
Device Name
BRONCHOSCOPY ELBOW
Manufacturer
RESPIRONICS, INC.
Date Cleared
2013-11-20

(131 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bronchoscopy Elbow can be used with Respironics Masks that incorporate the mating elbow hub design. Use of this elbow with these masks allows CPAP and bi-level the patient during a bronchoscopy procedure. The elbow is for single use in the hospital/institutional environment only.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Bronchoscopy Elbow." This type of document does not contain information about the acceptance criteria or the study that proves the device meets them. It primarily addresses the regulatory aspects of the device and its substantial equivalence to a predicate device.

Therefore, I cannot answer your request based on the given input, as the information you are asking for is not present in this document.

§ 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).