Last synced on 24 June 2022 at 11:05 pm

Valve, Non-Rebreathing

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5870
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5870 Nonrebreathing valve

§ 868.5870 Nonrebreathing valve.

(a) Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

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

Valve, Non-Rebreathing

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5870
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5870 Nonrebreathing valve

§ 868.5870 Nonrebreathing valve.

(a) Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

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