Cuffable

• • Terminated Z-2581-2011 FDA Unclassified (pre-2012) ·initiated 26 Apr 2011

  BP cuffs may not properly inflate due to a leak

510(k) Number

K911213 ↗

FDA Product Code

DXQ

Device Class

Class II

Regulation

21 CFR Part 870.1120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Correct Flo Intravascular Administration Set

  Class II

  FDA 510(k) K850506 Active Cleared 1 Apr 1985

• Pressure Infusor for I.V. Bags/Autoinflation

  Class II

  FDA 510(k) K890268 Active Cleared 5 May 1989

• Infusable

  Class I

  FDA 510(k) K911216 Active Cleared 22 Jul 1991

• Biomedical Dynamics Disposable Pressure Infusor

  Class I

  FDA 510(k) K861977 Active Cleared 15 Jul 1986

• Pressure Infuser

  Class I

  FDA 510(k) K913751 Active Cleared 9 Jan 1992

• Blood Pressure Cuff

  Class II

  FDA 510(k) K881799 Active Cleared 14 Oct 1988

See all devices from Biomedical Dynamics, Inc. →