D-Vapor

• • Terminated Z-1812-2016 FDA Class II ·initiated 21 Apr 2016

  Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.

510(k) Number

K042276 ↗

FDA Product Code

CAD

Device Class

Class II

Regulation

21 CFR Part 868.5880

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Narkomed MRI Anesthesia System

  Class II

  FDA 510(k) K972848 Active Cleared 30 Oct 1997

• Spectramed Respiratory Gas Analyzer

  Class II

  FDA 510(k) K873194 Active Cleared 30 Oct 1987

• Evite Xl

  Class II

  FDA 510(k) K083050 Active Cleared 29 Dec 2008

• Vapor 19

  Class II

  FDA 510(k) K771899 Active Cleared 18 Oct 1977

• Nbp Cuff

  Class II

  FDA 510(k) K092999 Active Cleared 24 Nov 2009

• Narkomed 6000 Model Number NM6000

  Class II

  FDA 510(k) K980553 Active Cleared 4 Aug 1998

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