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510(k) K960027

HIGH VOLUME I.V. & IRRIGATION TOWER by Allen Medical Systems, Inc. — Product Code FOX

K960027 is an FDA 510(k) premarket notification submitted by Allen Medical Systems, Inc. for the device "HIGH VOLUME I.V. & IRRIGATION TOWER". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Allen Medical Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
January 2, 1996
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 by Allen Medical Systems, Inc.

  • K971988 — ALLEN, ULTRA AND SMART SOCKETS (July 11, 1997)
  • K964273 — DURA-BOARD ARMBOARD (January 8, 1997)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
  • K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (April 21, 1993)

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)
  • K952196 — IV POLE/STAND (July 31, 1995)
  • K950367 — IV SHUTTLE (April 26, 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