Valve, Ambu Peep

• • Terminated Z-0533-2008 FDA Unclassified (pre-2012) ·initiated 21 Aug 2007

  Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.

510(k) Number

K782152 ↗

FDA Product Code

BYE

Device Class

Class II

Regulation

21 CFR Part 868.5965

Advisory Committee

Anesthesiology

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Air-Shields Resuscitators

  Class II

  FDA 510(k) K792118 Active Cleared 13 Nov 1979

• Isolette Incubator C-100

  Class II

  FDA 510(k) K802126 Active Cleared 26 Sep 1980

• System V.heart Rate/Respir. Rate Monit.

  Class II

  FDA 510(k) K820114 Active Cleared 12 Feb 1982

• Model 533 Phototherapy Unit

  Class II

  FDA 510(k) K810953 Active Cleared 23 Apr 1981

• Probe Cover

  Class II

  FDA 510(k) K810474 Active Cleared 31 Mar 1981

• Ambu Universal Suction Pump

  Class II

  FDA 510(k) K792592 Active Cleared 11 Jan 1980

See all devices from Narco Air-Shields →