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510(k) K033688

MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY by Micro Direct, Inc. — Product Code NRH

K033688 is an FDA 510(k) premarket notification submitted by Micro Direct, Inc. for the device "MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY". The FDA issued a decision of Substantially Equivalent on May 19, 2004. The device falls under product code NRH (System, Breath Measurement), a Class I device regulated under 21 CFR 862.1820. Micro Direct, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2004
Date Received
November 24, 2003
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 Micro Direct, Inc.

  • K031102 — MICROLAB SPIROMETER (December 1, 2003)
  • K030586 — MICROPEAK (August 27, 2003)
  • K973314 — SPIROSAFE FILTER (November 21, 1997)
  • K965042 — MICRODL DIARYCARD SPIROMETER (June 17, 1997)
  • K963376 — MICRO H2 (January 24, 1997)
  • K963035 — MICRO SPIROMETER (November 1, 1996)
  • K950197 — MICROCO (October 17, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

Other clearances for product code NRH

  • K963376 — MICRO H2 (January 24, 1997)
  • K882499 — JAYCO HYDROGEN MONITOR (June 28, 1988)
  • K874892 — VITALOGRAPH-EC60 HYDROGEN MONITOR (June 2, 1988)

FDA data resources