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510(k) K143148

Disposable Pressure Manometer (DPM) by Westmed, Inc. — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2015
Date Received
November 3, 2014
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 Westmed, Inc.

  • K162343 — Westmed Gas Sampling Cannula with O2 delivery (December 14, 2016)
  • K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR (May 23, 2014)
  • K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (December 6, 2012)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K072220 — PEDI CO2 EASY (August 23, 2007)
  • K070128 — CO2 EASY (February 15, 2007)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)

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)
  • 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)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)