Home / 510(k) Clearances / K963376

510(k) K963376

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

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)