Primus Us

• • Terminated Z-1955-2009 FDA Unclassified (pre-2012) ·initiated 17 Jul 2009 ·via K042607, on the same 510(k)

  Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.

• • Terminated Z-0087-2009 FDA Unclassified (pre-2012) ·initiated 22 Aug 2008

  Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K042607 ↗

FDA Product Code

BSZ

Device Class

Class II

Regulation

21 CFR Part 868.5160

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

See all devices from Draeger Medical, Inc. →