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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Breath Measurement
510(k) Number K874892
Device Name VITALOGRAPH-EC60 HYDROGEN MONITOR
Applicant
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Applicant Contact LOVINA G FREEMAN
Correspondent
Vitalograph , Ltd.
8347 Quivira Rd.
Lenexa,  KS  66215
Correspondent Contact LOVINA G FREEMAN
Regulation Number862.1820
Classification Product Code
NRH  
Date Received12/01/1987
Decision Date 06/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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