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Attachment, Intermittent Mandatory Ventilation (Imv)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5955
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5955 Intermittent mandatory ventilation attachment

§ 868.5955 Intermittent mandatory ventilation attachment.

(a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

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

Attachment, Intermittent Mandatory Ventilation (Imv)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5955
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5955 Intermittent mandatory ventilation attachment

§ 868.5955 Intermittent mandatory ventilation attachment.

(a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

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