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510(k) K120118

VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER by Ventlab Corp. — Product Code CAP

K120118 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER". The FDA issued a decision of Substantially Equivalent on May 24, 2012. 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. Ventlab Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2012
Date Received
January 17, 2012
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 Ventlab Corp.

  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K102674 — CUFF SENTRY (July 22, 2011)
  • K093617 — VENTLAB 6000 SERIES HUMIDIFIER (January 27, 2011)
  • K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT (December 10, 2009)
  • K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (June 25, 2009)
  • K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD (August 13, 2008)
  • K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (March 26, 2008)
  • K040726 — VENTLAB NASAL CPAP CANNULA (June 3, 2004)
  • K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100 (July 7, 2003)
  • K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM (February 11, 2002)

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

FDA data resources