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510(k) K900175

4/1 ARMBOARD by Infection Control Products, Inc. — Product Code BTX

K900175 is an FDA 510(k) premarket notification submitted by Infection Control Products, Inc. for the device "4/1 ARMBOARD". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Infection Control Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1990
Date Received
January 12, 1990
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 Infection Control Products, Inc.

  • K935779 — AGAFAR FACE SHIELD (February 1, 1994)
  • K900643 — FLUID SOAKERSHIELD (April 25, 1990)
  • K900644 — I.V. FREEDOM CLIP (March 9, 1990)

Other clearances for product code BTX

  • K935098 — BABY BOARD (February 15, 1994)
  • 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)
  • K792147 — ARM SHIELD FOR ANESTHESIA (December 6, 1979)

FDA data resources