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Ventilator, Emergency, Manual (Resuscitator)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5915
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5915 Manual emergency ventilator

§ 868.5915 Manual emergency ventilator.

(a) Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

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

Ventilator, Emergency, Manual (Resuscitator)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5915
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5915 Manual emergency ventilator

§ 868.5915 Manual emergency ventilator.

(a) Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

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