Cleared Traditional

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY

K033688 · Micro Direct, Inc. · Chemistry

May 2004

Decision

177d

Days

Class 1

Risk

About This 510(k) Submission

K033688 is an FDA 510(k) clearance for the MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY, a System, Breath Measurement (Class I — General Controls, product code NRH), submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on May 19, 2004, 177 days after receiving the submission on November 24, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1820.

Submission Details

510(k) Number	K033688 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2003
Decision Date	May 19, 2004
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NRH — System, Breath Measurement
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1820
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.