Company ยท US
Del Mar Reynolds Medical, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2007. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2007 | K062397 | SENTINEL Del Mar Reynolds Medical, Ltd. | DXH |
| Nov 3, 2006 | K062469 | VOYAGER 12 Del Mar Reynolds Medical, Ltd. | DPS |
| Aug 19, 2005 | K051960 | CARDIONAVIGATOR + Del Mar Reynolds Medical, Ltd. | DXH |
| Jan 19, 2005 | K042745 | LIFESCREEN APNEA Del Mar Reynolds Medical, Inc. | MNR |
| Apr 6, 2004 | K040313 | HRV TOOLS Del Mar Reynolds Medical, Ltd. | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2017 | Del 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 |
BSZ | K113051 |
| Feb 8, 2017 | Del 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 |
CBK | K113051 |
| Apr 20, 2015 | Del Mar Reynolds Medical, Ltd. Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators.
Designed specifically for the mechanical ventilation of adult and pediat Terminated |
CBK | K112729 |
| Apr 12, 2014 | Del Mar Reynolds Medical, Ltd. SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. Terminated |
CBK | K113051 |
| Nov 20, 2013 | Del Mar Reynolds Medical, Ltd. CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, Terminated |
BSZ | K003251 K010850 |
| Jul 19, 2013 | Del 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 |
CBK | K113051 |
| Mar 20, 2013 | Del Mar Reynolds Medical, Ltd. Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation Terminated |
CBK | K003251 K101850 |
| Dec 19, 2012 | Del Mar Reynolds Medical, Ltd. BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.
In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. I Terminated |
BSZ | K003251 |
| Jan 13, 2012 | Del Mar Reynolds Medical, Ltd. Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare faci Terminated |
DPS | K090367 |
| Jan 11, 2012 | Del Mar Reynolds Medical, Ltd. Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31.
Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea Terminated |
MNR | K042745 |
| Nov 29, 2011 | Del Mar Reynolds Medical, Ltd. Ambulatory Blood Pressure (ABP) Monitor, Model 90217A.
The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate m Terminated |
DXN | K103732 |
| Nov 21, 2011 | Del Mar Reynolds Medical, Ltd. PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads .
Ho Terminated |
KOY | None listed |