510(k) K033688

Device: MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
Applicant: MICRO DIRECT, INC.
510(k) number: K033688
Product code: NRH
Decision: Substantially Equivalent (SESE)
Decision date: 2004-05-19
Date received: 2003-11-24
Regulation: 862.1820
Classification name: System, Breath Measurement
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAVID STASZAK
Address: 803 Webster St. Lewiston ME US 04240 04240

FDA Registration Numbers#

3009896423
3014845771
3014937935
3006210673
9612890
3016854619
3012421607
3042956423
3009312584
3026284320
2124914
3014686722

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NRH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K963376	MICRO H2	Micro Direct, Inc.	1997-01-24
K882499	JAYCO HYDROGEN MONITOR	Enteron, Inc.	1988-06-28
K874892	VITALOGRAPH-EC60 HYDROGEN MONITOR	Vitalograph , Ltd.	1988-06-02

Legacy Summary#

summary

FDA Review#

Decision Summary