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510(k) K841901

OXYMIZER FLOW RESTRICTOR by Chad Therapeutics, Inc. — Product Code BYX

K841901 is an FDA 510(k) premarket notification submitted by Chad Therapeutics, Inc. for the device "OXYMIZER FLOW RESTRICTOR". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Chad Therapeutics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

Other clearances by Chad Therapeutics, Inc.

  • K081176 — FLOCHANNEL (July 28, 2008)
  • K070740 — CHAD THERAPEUTICS BONSAI MODEL 800 (May 7, 2007)
  • K042142 — CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S (September 20, 2004)
  • K033364 — CHAD THERAPEUTICS SAGE (May 11, 2004)
  • K020475 — CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 (July 5, 2002)
  • K013472 — TOTAL O2 (November 28, 2001)
  • K010389 — CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 (March 23, 2001)
  • K003455 — MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 (December 6, 2000)
  • K000890 — CHAD THERAPEUTICS OXYMATIC MODEL 401 (June 16, 2000)
  • K971889 — CHAD TOTAL O2 DELIVERY SYSTEM (November 17, 1997)

Other clearances for product code BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)

FDA data resources