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510(k) K900115

VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B by Ventlab Corp. — Product Code CAN

K900115 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Ventlab Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
January 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

Other clearances by Ventlab Corp.

  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • 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)

Other clearances for product code CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)

FDA data resources