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510(k) K853039

PRESSURE REGULATOR by Erie Medical — Product Code CAN

K853039 is an FDA 510(k) premarket notification submitted by Erie Medical for the device "PRESSURE REGULATOR". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Erie Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
July 19, 1985
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 Erie Medical

  • K861865 — ERIE-NEB (July 1, 1986)
  • K853051 — TRACHEAL TUBES (April 11, 1986)
  • K853040 — PRESSURE GAUGE (October 10, 1985)
  • K832466 — TRACHEAL TUBE 16 GAUGE-1.65MM- (September 19, 1984)

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