Blease 6200 Anaesthesia Ventilator

• • Terminated Z-0165-04 FDA Unclassified (pre-2012) ·initiated 31 Jul 2002 ·on shared 510(k) K982132

  Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.

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

510(k) Number

K982132 ↗

FDA Product Code

CBK

FDA applicant

Blease Medical Equipment , Ltd.

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to Blease Frontline Genius Range, Anesthesia Machines

  Class II

  FDA 510(k) K001727 Active Cleared 9 Aug 2000

• Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690

  Class II

  FDA 510(k) K003251 Active Cleared 23 May 2001

• Blease Sirius Anesthesia System, Models 3000 and 2000

  Class II

  FDA 510(k) K041430 Active Cleared 7 Oct 2004

• Blease Frontline Genius Range Anaesthesia Machine

  Class II

  FDA 510(k) K982137 Active Cleared 9 Apr 1999