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Mechanical Ventilator

Page Type
Product Code
Definition
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Physical State
A small, wearable ventilator that interfaces with proprietary nasal and tracheostomy patient interfaces.
Technical Method
The device consists of two components: a ventilator and a patient interface. The device is a light-weight, portable, electronically timed and controlled volume assist ventilator. The device delivers 100% oxygen in volumes of 50-250ml. The device delivers augmented volumes of 100% oxygen that are blended in the interface, patient's airway and lung with ambient air provided by the patient's spontaneous breath.
Target Area
The device delivers augmented volumes of 100% oxygen into the patient's airway.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5895
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5895 Continuous ventilator

§ 868.5895 Continuous ventilator.

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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

Mechanical Ventilator

Page Type
Product Code
Definition
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Physical State
A small, wearable ventilator that interfaces with proprietary nasal and tracheostomy patient interfaces.
Technical Method
The device consists of two components: a ventilator and a patient interface. The device is a light-weight, portable, electronically timed and controlled volume assist ventilator. The device delivers 100% oxygen in volumes of 50-250ml. The device delivers augmented volumes of 100% oxygen that are blended in the interface, patient's airway and lung with ambient air provided by the patient's spontaneous breath.
Target Area
The device delivers augmented volumes of 100% oxygen into the patient's airway.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5895
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5895 Continuous ventilator

§ 868.5895 Continuous ventilator.

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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