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510(k) K950367

IV SHUTTLE by Equipment Concepts, Inc. — Product Code FOX

K950367 is an FDA 510(k) premarket notification submitted by Equipment Concepts, Inc. for the device "IV SHUTTLE". The FDA issued a decision of Substantially Equivalent on April 26, 1995. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type

Other clearances for product code FOX

  • K980336 — IV STANDS (April 6, 1998)
  • K964782 — MEDRAD CONTRAST HOLDER (February 25, 1997)
  • K961470 — PORT-A-POLE (July 22, 1996)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 1996)
  • K952196 — IV POLE/STAND (July 31, 1995)
  • K946201 — STAND, INFUSION (April 18, 1995)
  • K944580 — FLEXSYS MOBILEMATE EQUIPMENT STAND (March 17, 1995)
  • K932498 — MOBILE CARE IV STAND (October 27, 1993)
  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)
  • K912010 — I.V. SKY-HOOK (August 19, 1991)

FDA data resources