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510(k) K884838

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

K884838 is an FDA 510(k) premarket notification submitted by Edgewater Medical Systems, Inc. for the device "ALLEN PRONE ARMBOARD". The FDA issued a decision of Substantially Equivalent on December 15, 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
December 15, 1988
Date Received
November 21, 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.

  • K881292 — ALLEN LATERAL ARMBOARD (April 7, 1988)

Other clearances for product code BTX

  • K935098 — BABY BOARD (February 15, 1994)
  • K900175 — 4/1 ARMBOARD (January 24, 1990)
  • 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