Home / 510(k) Clearances / K963376

510(k) K963376

MICRO H2 by Micro Direct, Inc. — Product Code NRH

K963376 is an FDA 510(k) premarket notification submitted by Micro Direct, Inc. for the device "MICRO H2". The FDA issued a decision of Substantially Equivalent on January 24, 1997. 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
January 24, 1997
Date Received
August 27, 1996
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.

  • K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (May 19, 2004)
  • K031102 — MICROLAB SPIROMETER (December 1, 2003)
  • K030586 — MICROPEAK (August 27, 2003)
  • K973314 — SPIROSAFE FILTER (November 21, 1997)
  • K965042 — MICRODL DIARYCARD SPIROMETER (June 17, 1997)
  • K963035 — MICRO SPIROMETER (November 1, 1996)
  • K950197 — MICROCO (October 17, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

Other clearances for product code NRH

  • K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (May 19, 2004)
  • K882499 — JAYCO HYDROGEN MONITOR (June 28, 1988)
  • K874892 — VITALOGRAPH-EC60 HYDROGEN MONITOR (June 2, 1988)

FDA data resources