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510(k) K110119

PRESSURE MANOMETER by Neoforce Group, Inc. — Product Code CAP

K110119 is an FDA 510(k) premarket notification submitted by Neoforce Group, Inc. for the device "PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on June 10, 2011. 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. Neoforce Group, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
January 18, 2011
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 Neoforce Group, Inc.

  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K102649 — NEOPOP INFANT RESUSCITATOR WITH FLOW METER (January 6, 2011)
  • K092085 — ISPIRA RESUSCITATION UNIT (October 7, 2009)
  • K072021 — NEOPIP INFANT RESUSCITATOR (September 12, 2007)
  • K070416 — NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (May 29, 2007)
  • K061280 — V-2200 INFANT INCUBATOR (June 27, 2006)

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