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Circulator, Breathing-Circuit

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5250 Breathing circuit circulator

§ 868.5250 Breathing circuit circulator.

(a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.

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

Circulator, Breathing-Circuit

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5250 Breathing circuit circulator

§ 868.5250 Breathing circuit circulator.

(a) Identification. A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.

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