Jayco Hydrogen Monitor

FDA 510(k) K882499 · Enteron, Inc.

Substantially Equivalent

510(k) numberK882499

Submission

Device name
Jayco Hydrogen Monitor
Applicant
Enteron, Inc.
Camp Hill, PA, US
Received
June 17, 1988
Decision date
June 28, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
NRH – System, Breath Measurement
Device class
Class I (low risk)
Regulation
21 CFR 862.1820
Specialty
Clinical Chemistry

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

Other 510(k)s with product code NRH

510(k)DeviceApplicantDecision
K033688Micro H2 Breath Monitoring Device with Hydra Software UtilityNRH · Traditional Micro Direct, Inc.05/19/2004SE
K963376Micro H2NRH · Traditional Micro Direct, Inc.01/24/1997SE
K874892VITALOGRAPH-EC60 Hydrogen MonitorNRH · Traditional Vitalograph , Ltd.06/02/1988SE

Questions and answers

When was Jayco Hydrogen Monitor cleared by the FDA?

Jayco Hydrogen Monitor (K882499) received a 510(k) decision of Substantially Equivalent on June 28, 1988, 11 days after the submission was received.

What is the product code of K882499?

The FDA product code is NRH – System, Breath Measurement, a Class I (low risk) device regulated under 21 CFR 862.1820.