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510(k) K802659

RESPIRATORY THERAPY FLOWMETER by Design & Manufacturing Consultants — Product Code CAX

K802659 is an FDA 510(k) premarket notification submitted by Design & Manufacturing Consultants for the device "RESPIRATORY THERAPY FLOWMETER". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 24, 1980
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 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)
  • 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)

FDA data resources