Home / 510(k) Clearances / K921125

510(k) K921125

AMBU OXYGEN REGULATOR by Amg, LLC — Product Code CAN

K921125 is an FDA 510(k) premarket notification submitted by Amg, LLC for the device "AMBU OXYGEN REGULATOR". The FDA issued a decision of Substantially Equivalent on September 17, 1992. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1992
Date Received
March 10, 1992
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 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)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)

FDA data resources