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510(k) K901623

AMBU OXYGEN REGULATOR by Flotec, Inc. — Product Code CAN

K901623 is an FDA 510(k) premarket notification submitted by Flotec, Inc. for the device "AMBU OXYGEN REGULATOR". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Flotec, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1990
Date Received
April 6, 1990
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 Flotec, Inc.

  • K970371 — FLOTEC OXYSAVRR (S) (July 10, 1997)

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