510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRHClass I

System, Breath Measurement

21 CFR 862.1820 / Clinical Chemistry
FDA source (opens on fda.gov)

NRH is the FDA product code for System, Breath Measurement, a class I device type, regulated under 21 CFR 862.1820. FDA's definition for this code reads: "Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NRH
Device name
System, Breath Measurement
FDA 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.
Regulation
21 CFR 862.1820
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
3

Clearances, product code NRH

By decision year
4 clearances under product code NRH with a decision year between 1988 and 2004, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NRH by decision year
YearClearances
19882
19971
20041

Applicants with the most clearances

Product code NRH
Applicants holding the most 510(k) clearances under product code NRH
ApplicantClearances
Micro Direct, Inc.2
Enteron, Inc.1
Vitalograph, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code