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510(k) K950777

OXYGEN REGULATOR by Mada Medical Products, Inc. — Product Code CAN

K950777 is an FDA 510(k) premarket notification submitted by Mada Medical Products, Inc. for the device "OXYGEN REGULATOR". The FDA issued a decision of Substantially Equivalent on April 14, 1995. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Mada Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1995
Date Received
February 21, 1995
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 Mada Medical Products, Inc.

  • K003862 — MADA WHEELCHAIRS (January 12, 2001)
  • K002943 — WHEELCHAIR, MECHANICAL SERIES MODEL 3100 (October 23, 2000)
  • K930949 — VOYAGE (June 1, 1993)
  • K930947 — PROMENADE (June 1, 1993)
  • K921611 — MADAVAC 190 (September 9, 1992)
  • K850754 — MEDAJET XL - JET INJECTOR (December 10, 1985)
  • K802426 — RESPO2 OXYGEN CONCENTRATOR (October 23, 1980)

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)
  • 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