Company ยท US
Spacelabs Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2012. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 17 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 7 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 |
| BSZ | Gas-Machine, Anesthesia | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| HGM | System, Monitoring, Perinatal | 2 |
| MSX | System, Network And Communication, Physiological Monitors | 2 |
| OLW | Index-Generating Electroencephalograph Software | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DQA | Oximeter | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 29, 2012 | K120616 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 Spacelabs Medical, Inc. | MHX |
| Nov 2, 2011 | K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) Spacelabs Medical, Inc. | MHX |
| Dec 7, 2010 | K102422 | SPACELABS MEDICAL PATIENT MONITORS Spacelabs Medical, Inc. | MHX |
| Nov 24, 2009 | K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION Spacelabs Medical, Inc. | MHX |
| Aug 1, 2008 | K082045 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 Spacelabs Medical, Inc. | MHX |
| Mar 15, 2007 | K063490 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 Spacelabs Medical, Inc. | DQK |
| Sep 29, 2006 | K062095 | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 Spacelabs Medical, Inc. | MHX |
| Sep 19, 2006 | K062278 | SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 Spacelabs Medical, Inc. | MSX |
| Jun 23, 2006 | K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 Spacelabs Medical, Inc. | OLW |
| Apr 19, 2006 | K053599 | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES Spacelabs Medical, Inc. | CBR |
| May 3, 2005 | K050605 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 Spacelabs Medical, Inc. | DSI |
| Mar 4, 2005 | K050175 | SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 Spacelabs Medical, Inc. | DSI |
| Aug 21, 2002 | K013046 | COSMOS SYSTEM Spacelabs Medical, Inc. | DSI |
| Jun 28, 2002 | K021097 | QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 Spacelabs Medical, Inc. | DSI |
| Jun 28, 2001 | K003663 | SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE Spacelabs Medical, Inc. | BSZ |
| Jan 14, 2000 | K992749 | ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841 Spacelabs Medical, Inc. | MSX |
| Dec 3, 1999 | K981655 | SPACELABS MEDICAL DISPOSABLE SP02 SENSOR Spacelabs Medical, Inc. | DQA |
| Jun 3, 1999 | K983996 | SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM Spacelabs Medical, Inc. | MHX |
| Nov 20, 1998 | K981530 | SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM Spacelabs Medical, Inc. | BSZ |
| May 28, 1998 | K972502 | SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 Spacelabs Medical, Inc. | DSI |
| Feb 3, 1998 | K973596 | SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE Spacelabs Medical, Inc. | OLW |
| Dec 16, 1997 | K965008 | BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM Spacelabs Medical, Inc. | HGM |
| Sep 25, 1997 | K972282 | SPACELABS MEDICAL PCIS PATIENT MONITORS Spacelabs Medical, Inc. | DSI |
| Jun 24, 1997 | K962811 | SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION Spacelabs Medical, Inc. | DXJ |
| Apr 25, 1997 | K962930 | SPACELABS MEDICAL ECG ANALYSIS SYSTEM Spacelabs Medical, Inc. | DQK |
| Apr 2, 1997 | K952912 | SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE Spacelabs Medical, Inc. | DSI |
| Mar 25, 1997 | K962970 | SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION Spacelabs Medical, Inc. | DSI |
| Sep 26, 1995 | K952885 | SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER Spacelabs Medical, Inc. | DSI |
| Aug 15, 1995 | K945429 | SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) Spacelabs Medical, Inc. | DSI |
| May 17, 1995 | K942058 | SPACELABS MEDICAL ECG MODULE (MODEL 90492) Spacelabs Medical, Inc. | DSI |
| Nov 14, 1994 | K941167 | NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553) Spacelabs Medical, Inc. | DXN |
| Oct 27, 1994 | K925510 | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING Spacelabs Medical, Inc. | DSI |
| Mar 2, 1994 | K932842 | SPACELABS MEDICAL MODEL 90481 EEG MODULE Spacelabs Medical, Inc. | GWQ |
| Nov 5, 1993 | K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY Spacelabs Medical, Inc. | DXJ |
| Sep 3, 1993 | K930095 | SPACELABS MEDICAL PATIENT MONITOR Spacelabs Medical, Inc. | DSI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2006 | Spacelabs Medical Incorporated Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver. Terminated |
DSI | K925510 |
| Feb 16, 2006 | Spacelabs Medical Incorporated Ultraview SL Capnography Module, Model 91517
A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ven Terminated |
CCK | K031124 |
| Nov 3, 2005 | Spacelabs Medical Incorporated Tru-Link DIN unshielded ECG cable, 5-lead Terminated |
DSI | K842616 |
| Nov 1, 2005 | Spacelabs Medical Incorporated BirthNet OB Data Management System 91861 Terminated |
HGM | K965008 |
| Jan 25, 2005 | Spacelabs Medical Incorporated Ultraview Universal Clinical Workstation System Model 90385. Terminated |
DXJ | K932724 |
| Jul 20, 2004 | Spacelabs Medical Inc. Ultraview 1700 Monitor Model 90387. Terminated |
DSI | None listed |
| Jul 20, 2004 | Spacelabs Medical Inc. Ultraview Universal Clinical Workstation Model 90385. Terminated |
DSI | None listed |