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510(k) K874892

VITALOGRAPH-EC60 HYDROGEN MONITOR by Vitalograph , Ltd. — Product Code NRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1988
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Breath Measurement
Device Class
Class I
Regulation Number
862.1820
Review Panel
CH
Submission Type

Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.

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