Ohmeda Excel 3000 Anesthesia System

• • Terminated Z-0967-04 FDA Unclassified (pre-2012) ·initiated 16 Apr 2004 ·on shared 510(k) K973896

  Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

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

510(k) Number

K973896 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ohmeda Medical →