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Meter, Peak Flow, Spirometry

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1860
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1860 Peak-flow meter for spirometry

§ 868.1860 Peak-flow meter for spirometry.

(a) Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

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

Meter, Peak Flow, Spirometry

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1860
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1860 Peak-flow meter for spirometry

§ 868.1860 Peak-flow meter for spirometry.

(a) Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

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