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Device Indicating An Exhalation Event

Page Type
Product Code
Definition
To provide visual indication of each exhalation event
Physical State
The device includes a thermistor that could detect the temperature change of breath. Supplemental oxygen could also be provided.
Technical Method
The device measures the time period between the current and previous exhalation and illuminates a different light during the exhalation that reflects the interval of time between breaths. This device does not calculate breath rate, e.g., breath rate per minute.
Target Area
oral/nasal area, face
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2375
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.2375 Breathing frequency monitor

§ 868.2375 Breathing frequency monitor.

(a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

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

[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]

Device Indicating An Exhalation Event

Page Type
Product Code
Definition
To provide visual indication of each exhalation event
Physical State
The device includes a thermistor that could detect the temperature change of breath. Supplemental oxygen could also be provided.
Technical Method
The device measures the time period between the current and previous exhalation and illuminates a different light during the exhalation that reflects the interval of time between breaths. This device does not calculate breath rate, e.g., breath rate per minute.
Target Area
oral/nasal area, face
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2375
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.2375 Breathing frequency monitor

§ 868.2375 Breathing frequency monitor.

(a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

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

[47 FR 31142, July 16, 1982, as amended at 67 FR 46852, July 17, 2002]