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Condenser, Heat And Moisture (Artificial Nose)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5375 Heat and moisture condenser (artificial nose)

§ 868.5375 Heat and moisture condenser (artificial nose).

(a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]

Condenser, Heat And Moisture (Artificial Nose)

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5375 Heat and moisture condenser (artificial nose)

§ 868.5375 Heat and moisture condenser (artificial nose).

(a) Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001]