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510(k) K874892

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

K874892 is an FDA 510(k) premarket notification submitted by Vitalograph , Ltd. for the device "VITALOGRAPH-EC60 HYDROGEN MONITOR". The FDA issued a decision of Substantially Equivalent on June 2, 1988. The device falls under product code NRH (System, Breath Measurement), a Class I device regulated under 21 CFR 862.1820. Vitalograph , Ltd. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Vitalograph , Ltd.

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K000599 — VITALOGRAPH BASE STATION (September 8, 2000)
  • K991412 — VITALOGRAPH MICRO (February 4, 2000)
  • K943678 — ELECTRONIC FLOW METER (December 14, 1995)
  • K950854 — VITALOGRAPH 2110 SOFTWARE INTERFACE (October 12, 1995)
  • K946075 — VITALOGRAPH MODEL 2120 (August 4, 1995)
  • K942779 — DISPOSABLE BACTERIOLOGICAL FILTER (July 13, 1994)
  • K925085 — ESCORT SPIROMETER (August 12, 1993)
  • K930085 — VITALOGRAPH DATA STORAGE SPIROMETER (July 26, 1993)
  • K912412 — VITALOGRAPH SPIROTRAC III (October 15, 1991)

Other clearances for product code NRH

  • K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (May 19, 2004)
  • K963376 — MICRO H2 (January 24, 1997)
  • K882499 — JAYCO HYDROGEN MONITOR (June 28, 1988)

FDA data resources