Product Code: NRH FDA class 1 21 CFR 862.1820

System, Breath Measurement

Clinical Chemistry

The Breath Measurement System is a diagnostic device used to measure specific constituents of exhaled breath as an aid in the diagnosis of sugar and nutrient malabsorption and other related conditions. By analyzing breath samples, these systems can help clinicians identify gastrointestinal disorders in a noninvasive manner. This is an FDA Class 1 device regulated under 21 CFR 862.1820 in the Clinical Chemistry specialty, with product code NRH, and is exempt from premarket notification. It carries no implant or life-sustaining support designation.

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Basic Information

Product Code: NRH
Device Class: FDA class 1
Regulation Number: 862.1820
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K033688	MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY	May 19, 2004	Substantially Equivalent	Micro Direct, Inc.
K963376	MICRO H2	Jan 24, 1997	Substantially Equivalent	Micro Direct, Inc.
K882499	JAYCO HYDROGEN MONITOR	Jun 28, 1988	Substantially Equivalent	Enteron, Inc.
K874892	VITALOGRAPH-EC60 HYDROGEN MONITOR	Jun 02, 1988	Substantially Equivalent	Vitalograph , Ltd.