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510(k) K813197

OXYGEN CONNECTING TUBE by Northern Medical Industries — Product Code BYX

K813197 is an FDA 510(k) premarket notification submitted by Northern Medical Industries for the device "OXYGEN CONNECTING TUBE". The FDA issued a decision of Substantially Equivalent on Dec 18, 1981. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Northern Medical Industries has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 18, 1981
Date Received
Nov 13, 1981
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 Northern Medical Industries

  • K813163 — SUCTION CATHETER (Dec 29, 1981)
  • K813228 — CONNECTING TUBE (Nov 27, 1981)

Other clearances for product code BYX

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

FDA data resources