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Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.2600 Airway pressure monitor

§ 868.2600 Airway pressure monitor.

(a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

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

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2600
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.2600 Airway pressure monitor

§ 868.2600 Airway pressure monitor.

(a) Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

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