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510(k) K011134

OXYGEN SUPPLY TUBING, MODEL 1115 by Hudson Respiratory Care, Inc. — Product Code BYX

K011134 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "OXYGEN SUPPLY TUBING, MODEL 1115". The FDA issued a decision of Substantially Equivalent on June 13, 2001. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
April 13, 2001
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 Hudson Respiratory Care, Inc.

  • K031383 — MODEL 780 (July 7, 2003)
  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K010402 — SMOOTH-FLO CIRCUIT (March 14, 2001)
  • K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, (November 3, 2000)
  • K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-4 (May 24, 2000)
  • K994352 — SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 (March 22, 2000)
  • K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (February 21, 1997)
  • K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA (September 10, 1996)
  • K961914 — BACTERIA/VIRAL FILTER (August 14, 1996)
  • K955645 — CATH-GUIDE (March 12, 1996)

Other clearances for product code BYX

  • 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)
  • K905094 — SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (November 20, 1990)

FDA data resources