Cleared Traditional

VITALOGRAPH-EC60 HYDROGEN MONITOR

K874892 · Vitalograph , Ltd. · Chemistry

Jun 1988

Decision

184d

Days

Class 1

Risk

About This 510(k) Submission

K874892 is an FDA 510(k) clearance for the VITALOGRAPH-EC60 HYDROGEN MONITOR, a System, Breath Measurement (Class I — General Controls, product code NRH), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1988, 184 days after receiving the submission on December 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1820.

Submission Details

510(k) Number	K874892 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 1987
Decision Date	June 02, 1988
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

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.