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510(k) K781233

IV ARMBOARDS by Fibre Formations, Inc. — Product Code BTX

K781233 is an FDA 510(k) premarket notification submitted by Fibre Formations, Inc. for the device "IV ARMBOARDS". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Fibre Formations, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
July 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Board, Arm (With Cover), Sterile
Device Class
Class I
Regulation Number
878.3910
Review Panel
SU
Submission Type

Other clearances by Fibre Formations, Inc.

  • K791709 — HEEL/ELBOW PROTECTORS (September 24, 1979)
  • K790922 — DISPOSABLE ADULT DIAPER (July 30, 1979)
  • K781930 — PANT LINER, DISP. INCONTINENT (February 1, 1979)
  • K781246 — FOAM COMFORT RINGS (August 10, 1978)

Other clearances for product code BTX

  • K935098 — BABY BOARD (February 15, 1994)
  • K900175 — 4/1 ARMBOARD (January 24, 1990)
  • K884838 — ALLEN PRONE ARMBOARD (December 15, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K881292 — ALLEN LATERAL ARMBOARD (April 7, 1988)
  • K864670 — BOARD, ARM (WITH COVER) (January 12, 1987)
  • K833664 — ARMBOARD AND THE BOARD (December 27, 1983)
  • K830018 — SAFE-T ARM BOARD (January 26, 1983)
  • K823412 — ARM BOARD W/I.V COVERING (December 15, 1982)
  • K811419 — SPRIO-LOOP (June 12, 1981)

FDA data resources