Home / 510(k) Clearances / K871452

510(k) K871452

CLASSIC (TM) 200 OXYGEN FLOWMETER by The Timeter Group — Product Code CAX

K871452 is an FDA 510(k) premarket notification submitted by The Timeter Group for the device "CLASSIC (TM) 200 OXYGEN FLOWMETER". The FDA issued a decision of Substantially Equivalent on June 22, 1987. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. The Timeter Group has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1987
Date Received
April 13, 1987
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 The Timeter Group

  • K862171 — MP-500 ELECTRONIC NEBULIZER (July 14, 1986)
  • K852374 — OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18 (July 12, 1985)
  • K844556 — KHM 2000 DRIP WATCHER (January 14, 1985)

Other clearances for product code CAX

  • K923781 — MXR-2000 FLOWMETER (June 10, 1993)
  • K910316 — OHMEDA - LOW FLOW FLOWMETER (April 12, 1991)
  • K884973 — FR6000 FLOWMETER (January 17, 1989)
  • K872718 — SERIES D FLOWMETER (August 5, 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