Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40, 780-41, 780-42, 780-43

• • Terminated Z-2790-2011 FDA Unclassified (pre-2012) ·initiated 6 Jun 2011

  The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed.

510(k) Number

K993355 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Dual Lumen Oxygen Delivery Gas Sampling Cannula

  Class II

  FDA 510(k) K961150 Active Cleared 10 Sep 1996

• Conchatherm IV Heated Molecular Humidifier

  Class II

  FDA 510(k) K923946 Active Cleared 18 Oct 1994

• Smooth-Flo Circuit

  Class II

  FDA 510(k) K010402 Active Cleared 14 Mar 2001

• Model 780 Open recall

  Class II

  FDA 510(k) K031383 Active Cleared 7 Jul 2003

• Hudson Rci Lifesaver Single Patient Use Manual Resuscitator

  Class II

  FDA 510(k) K964719 Active Cleared 21 Feb 1997

• Side Draft Neb-U-Mist Nebulizer, Model 41896

  Class II

  FDA 510(k) K994352 Active Cleared 22 Mar 2000

See all devices from Hudson Respiratory Care, Inc. →