System, Breath Measurement

NRH · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1820

Classification

FDA Product Code: NRH
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.1820
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 4
Registered establishments: 12

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown