Micro H2 Breath Monitoring Device with Hydra Software Utility

FDA 510(k) K033688 · Micro Direct, Inc.

Substantially Equivalent

510(k) numberK033688

Submission

Device name
Micro H2 Breath Monitoring Device with Hydra Software Utility
Applicant
Micro Direct, Inc.
Lewiston, ME, US
Received
November 24, 2003
Decision date
May 19, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
K963376Micro H2NRH · Traditional Micro Direct, Inc.01/24/1997SE
K882499Jayco Hydrogen MonitorNRH · Traditional Enteron, Inc.06/28/1988SE
K874892VITALOGRAPH-EC60 Hydrogen MonitorNRH · Traditional Vitalograph , Ltd.06/02/1988SE

More from Vitalograph , Ltd.

510(k)DeviceDecision
K031102Microlab SpirometerBZG · Traditional 12/01/2003SE
K030586MicropeakBZH · Traditional 08/27/2003SE
K973314Spirosafe FilterCAH · Traditional 11/21/1997SE
K965042Microdl Diarycard SpirometerBZG · Traditional 06/17/1997SE
K963376Micro H2NRH · Traditional 01/24/1997SE
K963035Micro SpirometerBZG · Traditional 11/01/1996SE
K950197MicrocoCCJ · Traditional 10/17/1996SE
K940375Micro MPMCAP · Traditional 11/21/1994SE

Questions and answers

When was Micro H2 Breath Monitoring Device with Hydra Software Utility cleared by the FDA?

Micro H2 Breath Monitoring Device with Hydra Software Utility (K033688) received a 510(k) decision of Substantially Equivalent on May 19, 2004, 177 days after the submission was received.

What is the product code of K033688?

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