ClearanceBrief
510(k) K113051 ยท CBK Ventilator, Continuous, Facility Use

SPACELABS ARKON ANESTHESIA WORKSTATION

ApplicantSpacelabs Healthcare, Nederland CO, US
DecisionSubstantially Equivalent, Mar 22, 2012
ReceivedOct 13, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113051

DateFirm and productCodeLinked 510(k)
Aug 10, 2018Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia
Terminated		 CBKNone listed
Nov 21, 2017Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment
Terminated		 BSZNone listed
Apr 14, 2017Del Mar Reynolds Medical, Ltd.
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Ad
Terminated		 BSZNone listed
Feb 8, 2017Del Mar Reynolds Medical, Ltd.
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual
Terminated		 CBKNone listed
Apr 12, 2014Del Mar Reynolds Medical, Ltd.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Terminated		 CBKNone listed
Jul 19, 2013Del Mar Reynolds Medical, Ltd.
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circu
Terminated		 CBKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.