BTX · Class I · 21 CFR 878.3910

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

Leading manufacturers include Sage Products, Inc., Anago, Inc. and Karlin Technology, Inc..

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 Jul 08, 1988
UNIVERSALLY ADJUSTABLE ARMBOARD
K882524
Karlin Technology, Inc.
General & Plastic Surgery · 21d
Cleared Jan 12, 1987
BOARD, ARM (WITH COVER)
K864670
Anago, Inc.
General & Plastic Surgery · 41d
Cleared Dec 15, 1982
ARM BOARD W/I.V COVERING
K823412
Sage Products, Inc.
General & Plastic Surgery · 30d
Cleared Dec 06, 1979
ARM SHIELD FOR ANESTHESIA
K792147
Medical Innovations Corp.
General & Plastic Surgery · 45d

About Product Code BTX - Regulatory Context