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510(k) K864670

BOARD, ARM (WITH COVER) by Anago, Inc. — Product Code BTX

K864670 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "BOARD, ARM (WITH COVER)". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 2, 1986
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 Anago, Inc.

  • K925659 — U.C.E.Z. LENS CLEANER KIT (September 17, 1993)
  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K920615 — ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (March 20, 1993)
  • K915415 — GUARDALL SHIELD (October 15, 1992)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)

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)
  • 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