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510(k) K852300

INOX IV STAND by Broadwest Corp. — Product Code FOX

K852300 is an FDA 510(k) premarket notification submitted by Broadwest Corp. for the device "INOX IV STAND". The FDA issued a decision of Substantially Equivalent on June 20, 1985. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Broadwest Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
May 29, 1985
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 Broadwest Corp.

  • K864499 — PODOSCOPE (February 4, 1987)
  • K864569 — PODODIGITAL (February 4, 1987)
  • K852302 — INOX IORCEPS JAR (July 2, 1985)
  • K852301 — INOX THERMOMETER JAR (July 1, 1985)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)

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)
  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)

FDA data resources