Last synced on 20 May 2022 at 11:05 pm

Calculator, Predicted Values, Pulmonary Function

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1890 Predictive pulmonary-function value calculator

§ 868.1890 Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

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

Calculator, Predicted Values, Pulmonary Function

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.1890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 868.1890 Predictive pulmonary-function value calculator

§ 868.1890 Predictive pulmonary-function value calculator.

(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

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