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510(k) K905094

SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN by Medical Fittings, Inc. — Product Code BYX

K905094 is an FDA 510(k) premarket notification submitted by Medical Fittings, Inc. for the device "SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Medical Fittings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
November 13, 1990
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 Medical Fittings, Inc.

  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K920360 — TIMOX OXYGEN TIMER (August 3, 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)
  • K904701 — MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN (October 31, 1990)
  • K904757 — OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (October 31, 1990)
  • K904702 — MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS (October 31, 1990)
  • K904337 — OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN. (October 4, 1990)

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