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510(k) K153733

VORTRAN Manometer by Vortran Medical Technology 1, Inc. — Product Code CAP

K153733 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "VORTRAN Manometer". The FDA issued a decision of Substantially Equivalent on September 16, 2016. 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. Vortran Medical Technology 1, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2016
Date Received
December 28, 2015
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 Vortran Medical Technology 1, Inc.

  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)
  • K073261 — VAR MONITOR (May 23, 2008)
  • K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (July 15, 2004)
  • K003684 — PERCUSSIVENEB, MODEL PN-2001 (February 23, 2001)
  • K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (July 5, 2000)
  • K982016 — PIPER IPPB MODEL 2055 (November 3, 1998)

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

FDA data resources