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510(k) K162811

MR Conditional CGA 870 by Essex Industries, Inc. — Product Code CAN

K162811 is an FDA 510(k) premarket notification submitted by Essex Industries, Inc. for the device "MR Conditional CGA 870". The FDA issued a decision of Substantially Equivalent on March 2, 2017. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Essex Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2017
Date Received
October 6, 2016
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 Essex Industries, Inc.

  • K161472 — Walk-O2-Bout (November 18, 2016)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)

Other clearances for product code CAN

  • 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)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)

FDA data resources