Lds Peep Valve

• • Terminated Z-1380-2008 FDA Unclassified (pre-2012) ·initiated 4 Mar 2008

  Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.

510(k) Number

K854822 ↗

FDA Product Code

BYE

Device Class

Class II

Regulation

21 CFR Part 868.5965

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Headstrap

  Class I

  FDA 510(k) K854537 Active Cleared 3 Dec 1985

• Modified Cushion-Flex(Tm)

  Class I

  FDA 510(k) K890108 Active Cleared 24 Jan 1989

• Modification Manual Pulmon Resuscitor/Pulmanex(Tm)

  Class II

  FDA 510(k) K913714 Active Cleared 1 Dec 1992

• Flow Generator for Sleep Apnea, Lds 1500

  Class II

  FDA 510(k) K862448 Active Cleared 14 Nov 1986

• Pulmanex

  Class II

  FDA 510(k) K854037 Active Cleared 1 Nov 1985

• Cushion Flex(Tm)

  Class I

  FDA 510(k) K884387 Active Cleared 17 Nov 1988

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