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510(k) K760314

FLOWMETER, OXYGEN by Harris-Lake, Inc. — Product Code CAX

K760314 is an FDA 510(k) premarket notification submitted by Harris-Lake, Inc. for the device "FLOWMETER, OXYGEN". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Harris-Lake, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 26, 1976
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 Harris-Lake, Inc.

  • K761293 — RESPIRATORY HUMIDIFIER (January 3, 1977)
  • K761294 — RESPIRATORY BLOWER (January 3, 1977)
  • K761295 — RESP. AIR TEMP. CONTROL & HAZARD MON. (December 30, 1976)
  • K760333 — JAR, COLLECTOR FOR SUCTION SYSTEMS (October 27, 1976)
  • K760316 — REGULATORS, LOW SUCTION (August 4, 1976)
  • K760317 — REGULATORS, HIGH SUCTION (August 4, 1976)

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