Home / 510(k) Clearances / K940375

510(k) K940375

MICRO MPM by Micro Direct, Inc. — Product Code CAP

K940375 is an FDA 510(k) premarket notification submitted by Micro Direct, Inc. for the device "MICRO MPM". The FDA issued a decision of Substantially Equivalent on November 21, 1994. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Micro Direct, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1994
Date Received
January 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
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)
  • K950197 — MICROCO (October 17, 1996)

Other clearances for product code CAP

  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)

FDA data resources