Last synced on 24 June 2022 at 11:05 pm

Airway Monitoring System

Page Type
Product Code
Definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Physical State
The device is comprised of a small monitor and a sterile, single use adapter.
Technical Method
The device uses acoustic reflection technologyto generate an audible sound signal from a speaker and two microphones that receive acoustic reflections that arise from within the ETT tube
Target Area
The device is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient who is connected to a ventilator.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5730 Tracheal tube

§ 868.5730 Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

(b) Classification. Class II (performance standards).

Airway Monitoring System

Page Type
Product Code
Definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Physical State
The device is comprised of a small monitor and a sterile, single use adapter.
Technical Method
The device uses acoustic reflection technologyto generate an audible sound signal from a speaker and two microphones that receive acoustic reflections that arise from within the ETT tube
Target Area
The device is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient who is connected to a ventilator.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5730 Tracheal tube

§ 868.5730 Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

(b) Classification. Class II (performance standards).