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510(k) K961470

PORT-A-POLE by Prins Medical Ind., Inc. — Product Code FOX

K961470 is an FDA 510(k) premarket notification submitted by Prins Medical Ind., Inc. for the device "PORT-A-POLE". The FDA issued a decision of Substantially Equivalent on July 22, 1996. 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
July 22, 1996
Date Received
April 17, 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 for product code FOX

  • K980336 — IV STANDS (April 6, 1998)
  • K964782 — MEDRAD CONTRAST HOLDER (February 25, 1997)
  • 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)
  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)
  • K912010 — I.V. SKY-HOOK (August 19, 1991)

FDA data resources