Cleared Traditional

MICRO H2

K963376 · Micro Direct, Inc. · Chemistry

Jan 1997

Decision

150d

Days

Class 1

Risk

About This 510(k) Submission

K963376 is an FDA 510(k) clearance for the MICRO H2, a System, Breath Measurement (Class I — General Controls, product code NRH), submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on January 24, 1997, 150 days after receiving the submission on August 27, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1820.

Submission Details

510(k) Number	K963376 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 1996
Decision Date	January 24, 1997
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

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.