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510(k) K874892

Device
VITALOGRAPH-EC60 HYDROGEN MONITOR
Applicant
VITALOGRAPH LTD.
510(k) number
K874892
Product code
NRH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-02
Date received
1987-12-01
Regulation
862.1820
Classification name
System, Breath Measurement
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LOVINA G FREEMAN
Address
8347 Quivira Rd. Lenexa KS US 66215 66215

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
K963376MICRO H2Micro Direct, Inc.1997-01-24
K882499JAYCO HYDROGEN MONITOREnteron, Inc.1988-06-28

Legacy Summary#

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FDA Review#

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