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Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1120 Blood gases (P<sub>CO2</sub>, P<sub>O2</sub>) and blood pH test system

§ 862.1120 Blood gases (PCO2, PO2) and blood pH test system.

(a) Identification. A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II.

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1120
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1120 Blood gases (P<sub>CO2</sub>, P<sub>O2</sub>) and blood pH test system

§ 862.1120 Blood gases (PCO2, PO2) and blood pH test system.

(a) Identification. A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

(b) Classification. Class II.