Hudson Rci Lifesaver Single Patient Use Manual Resuscitator

• • Terminated Z-1809-2015 FDA Class I ·initiated 14 May 2015

  The intake port may be blocked which can cause the bag to fail to fill.

510(k) Number

K964719 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K011134 Active Cleared 13 Jun 2001

See all devices from Hudson Respiratory Care, Inc. →