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510(k) K881292

ALLEN LATERAL ARMBOARD by Edgewater Medical Systems, Inc. — Product Code BTX

K881292 is an FDA 510(k) premarket notification submitted by Edgewater Medical Systems, Inc. for the device "ALLEN LATERAL ARMBOARD". The FDA issued a decision of Substantially Equivalent on April 7, 1988. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Edgewater Medical Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1988
Date Received
March 28, 1988
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 Edgewater Medical Systems, Inc.

  • K884838 — ALLEN PRONE ARMBOARD (December 15, 1988)

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)
  • 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