Home / 510(k) Clearances / K910316

510(k) K910316

OHMEDA - LOW FLOW FLOWMETER by Ohmeda Medical — Product Code CAX

K910316 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA - LOW FLOW FLOWMETER". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Device Class
Class I
Regulation Number
868.2340
Review Panel
AN
Submission Type

Other clearances by Ohmeda Medical

  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K101778 — GIRAFFE INCUBATOR (July 21, 2010)
  • K101788 — GIRAFFE OMNIBED (July 21, 2010)
  • K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER (April 16, 2009)
  • K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW (August 27, 2007)
  • K070377 — GIRAFFE AND PANDA WARMER (July 11, 2007)
  • K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (April 20, 2007)
  • K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (April 20, 2007)
  • K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (April 16, 2004)
  • K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED (May 9, 2002)

Other clearances for product code CAX

  • K923781 — MXR-2000 FLOWMETER (June 10, 1993)
  • K884973 — FR6000 FLOWMETER (January 17, 1989)
  • K872718 — SERIES D FLOWMETER (August 5, 1987)
  • K871452 — CLASSIC (TM) 200 OXYGEN FLOWMETER (June 22, 1987)
  • K862797 — AIRCO 2000 SERIES FLOWMETERS (August 8, 1986)
  • K854067 — SELECT FLOWMETER (October 29, 1985)
  • K851288 — OXYGEN DELIVERY MEASURING DEVICE (September 3, 1985)
  • K850559 — PRESSURE RELIEF ADAPTOR (April 25, 1985)
  • K850560 — FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE (April 17, 1985)
  • K834260 — RECON-2 FLOW CONTROLLER (January 10, 1984)

FDA data resources