Last synced on 20 May 2022 at 11:05 pm

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5270
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5270 Breathing system heater

§ 868.5270 Breathing system heater.

(a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

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

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5270
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5270 Breathing system heater

§ 868.5270 Breathing system heater.

(a) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

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