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System, Breath Measurement

FDA product code NRH · 4 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1820
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1988-06-02 – 2004-05-19

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

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