BTX · Class I · 21 CFR 878.3910

FDA Product Code BTX: Board, Arm (with Cover), Sterile

Leading manufacturers include Edgewater Medical Systems, Inc., Sage Products, Inc. and Harvey A. Turner, M.D..

13
Total
13
Cleared
34d
Avg days
1977
Since

FDA 510(k) Cleared Board, Arm (with Cover), Sterile Devices (Product Code BTX)

13 devices
1–13 of 13
Cleared Feb 15, 1994
BABY BOARD
K935098
Sentry Medical Products, Inc.
General & Plastic Surgery · 113d
Cleared Jan 24, 1990
4/1 ARMBOARD
K900175
Infection Control Products, Inc.
General & Plastic Surgery · 12d
Cleared Dec 15, 1988
ALLEN PRONE ARMBOARD
K884838
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Jul 08, 1988
UNIVERSALLY ADJUSTABLE ARMBOARD
K882524
Karlin Technology, Inc.
General & Plastic Surgery · 21d
Cleared Apr 07, 1988
ALLEN LATERAL ARMBOARD
K881292
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 10d
Cleared Jan 12, 1987
BOARD, ARM (WITH COVER)
K864670
Anago, Inc.
General & Plastic Surgery · 41d
Cleared Dec 27, 1983
ARMBOARD AND THE BOARD
K833664
Rick Robbin & Frederick Auerbach
General & Plastic Surgery · 70d
Cleared Jan 26, 1983
SAFE-T ARM BOARD
K830018
Harvey A. Turner, M.D.
General & Plastic Surgery · 23d
Cleared Dec 15, 1982
ARM BOARD W/I.V COVERING
K823412
Sage Products, Inc.
General & Plastic Surgery · 30d
Cleared Jun 12, 1981
SPRIO-LOOP
K811419
Datamed, Inc.
General & Plastic Surgery · 24d
Cleared Dec 06, 1979
ARM SHIELD FOR ANESTHESIA
K792147
Medical Innovations Corp.
General & Plastic Surgery · 45d
Cleared Aug 14, 1978
IV ARMBOARDS
K781233
Fibre Formations, Inc.
General & Plastic Surgery · 26d
Cleared Mar 07, 1977
COVER, ARMBOARD, DISPOSABLE
K770391
Precept, Inc.
General & Plastic Surgery · 7d

About Product Code BTX - Regulatory Context