Medical Air Compressor, Model # 8413419

• • Terminated Z-0674-2007 FDA Unclassified (pre-2012) ·initiated 26 Jan 2007

  Compressors not providing sufficient supply pressure to connected medical ventilator

510(k) Number

K982789 ↗

FDA Product Code

BTI

Device Class

Class II

Regulation

21 CFR Part 868.6250

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• Evita

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• Neoflow Option Model Numbers 8413563, 8411900

  Class II

  FDA 510(k) K983219 Active Cleared 7 Dec 1998

See all devices from Drager, Inc. →