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510(k) K963376

Device
MICRO H2
Applicant
MICRO DIRECT, INC.
510(k) number
K963376
Product code
NRH  
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-24
Date received
1996-08-27
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID STASZAK
Address
P.O. Box 239 840 Pownal Rd. Auburn ME US 04210 04210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NRH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYMicro Direct, Inc.2004-05-19
K882499JAYCO HYDROGEN MONITOREnteron, Inc.1988-06-28
K874892VITALOGRAPH-EC60 HYDROGEN MONITORVitalograph , Ltd.1988-06-02

Legacy Summary#

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FDA Review#

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