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510(k) K923781

MXR-2000 FLOWMETER by Porter Instrument Co., Inc. — Product Code CAX

K923781 is an FDA 510(k) premarket notification submitted by Porter Instrument Co., Inc. for the device "MXR-2000 FLOWMETER". The FDA issued a decision of Substantially Equivalent on June 10, 1993. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Porter Instrument Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1993
Date Received
July 28, 1992
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 Porter Instrument Co., Inc.

  • K062155 — DIGITAL MXR-D FLOWMETER (November 9, 2006)
  • K981754 — AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 (June 16, 1998)
  • K924596 — SES-2012 AUTOMATIC STEAM STERILIZER (April 15, 1994)
  • K895638 — STEAM STERILIZER (AUTOCLAVE), DENTAL (February 22, 1990)
  • K802067 — CLEAN-AIR POLLUTION REDUCTION SYSTEM (September 26, 1980)

Other clearances for product code CAX

  • 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)
  • K834260 — RECON-2 FLOW CONTROLLER (January 10, 1984)

FDA data resources