Model 1700 Tranquility Bilevel System

• • Terminated Z-1056-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007

  Foreign material: Glass fragments may present in the plastic bag material used to ship components.

510(k) Number

K970173 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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