Home / 510(k) Clearances / K950197

510(k) K950197

MICROCO by Micro Direct, Inc. — Product Code CCJ

K950197 is an FDA 510(k) premarket notification submitted by Micro Direct, Inc. for the device "MICROCO". The FDA issued a decision of Substantially Equivalent on October 17, 1996. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Micro Direct, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1996
Date Received
January 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

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)
  • K963376 — MICRO H2 (January 24, 1997)
  • K963035 — MICRO SPIROMETER (November 1, 1996)
  • K940375 — MICRO MPM (November 21, 1994)

Other clearances for product code CCJ

  • K253119 — CoSense ETCO Monitor (May 29, 2026)
  • K211918 — iCOquit® Smokerlyzer® (December 21, 2021)
  • K201206 — Pivot Breath Sensor (June 30, 2021)
  • K173238 — ToxCO (April 4, 2019)
  • K171129 — CO Check Pro, CO Screen (March 2, 2018)
  • K171408 — Carbon Monoxide Breath Sensor System (COBSS) (September 29, 2017)
  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)
  • K121768 — COSENSE (October 31, 2012)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)

FDA data resources