Last synced on 27 May 2022 at 11:05 pm

Vaporizer, Anesthesia, Non-Heated

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5880 Anesthetic vaporizer

§ 868.5880 Anesthetic vaporizer.

(a) Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

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

Vaporizer, Anesthesia, Non-Heated

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.5880 Anesthetic vaporizer

§ 868.5880 Anesthetic vaporizer.

(a) Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

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