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510(k) K925066

PNEUMATIC IRRIGATION STANDARD by Arthrodyn, Inc. — Product Code FOX

K925066 is an FDA 510(k) premarket notification submitted by Arthrodyn, Inc. for the device "PNEUMATIC IRRIGATION STANDARD". The FDA issued a decision of Substantially Equivalent on July 28, 1993. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Arthrodyn, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1993
Date Received
October 6, 1992
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 Arthrodyn, Inc.

  • K924326 — ARTHRODYN 45 DEGREE X-RAY TABLE (April 8, 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)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 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)
  • K912010 — I.V. SKY-HOOK (August 19, 1991)

FDA data resources