Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models Be 183-Sur

• • Terminated Z-1125-2013 FDA Class II ·initiated 7 Sep 2012

  Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

• • Terminated Z-0555-04 FDA Unclassified (pre-2012) ·initiated 12 Sep 2003 ·on shared 510(k) K991785

  possible external debris in the on/off plunger.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K991785 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Non-Rebreathing 't' (Be 117)

  Class II

  FDA 510(k) K973066 Active Cleared 3 Feb 1998

• Be 410 Endotracheal Tube/Trach Tube, Pilot Repair

  Class II

  FDA 510(k) K884638 Active Cleared 23 Nov 1988

• Sg-066 Oxygen Enrichment Kit

  Class II

  FDA 510(k) K860077 Active Cleared 18 Feb 1986

• Gas Collhctor Be 155(155-2-3, 154-4)

  Class I

  FDA 510(k) K770632 Active Cleared 8 Apr 1977

• Ms-303-Oxygen Regulator Shield

  Class I

  FDA 510(k) K810679 Active Cleared 17 Apr 1981

• Flex Arm Be 122, Clamp 122-27

  Class I

  FDA 510(k) K770631 Active Cleared 23 May 1977

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