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510(k) K894302

OXYGEN THERAPY REGULATOR by Modern Engineering Co., Inc. — Product Code CAN

K894302 is an FDA 510(k) premarket notification submitted by Modern Engineering Co., Inc. for the device "OXYGEN THERAPY REGULATOR". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Modern Engineering Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1989
Date Received
May 3, 1989
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 Modern Engineering Co., Inc.

  • K894850 — 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI (August 31, 1989)

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