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510(k) K791900

M015 OXYGEN & MA15 AIR by Timeter Instrument Corp. — Product Code CAX

K791900 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "M015 OXYGEN & MA15 AIR". The FDA issued a decision of Substantially Equivalent on October 11, 1979. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1979
Date Received
September 25, 1979
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 Timeter Instrument Corp.

  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K871603 — CRITERION II & IIA OXYGEN CONCENTRATORS (August 13, 1987)
  • K864836 — L.A.P. SPIROMETER (March 6, 1987)
  • K834274 — CRITERION I (April 13, 1984)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • K822746 — RT-200 CALIBRATION ANALYZER (October 13, 1982)
  • K812766 — PCS-5 ACCESSORIES (December 17, 1981)
  • K813234 — OHIO AIR ADAPTOR (December 8, 1981)
  • K813235 — DISS FEMALE AIR ADAPTOR (December 8, 1981)

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