Spacelabs Medical Integrated Clinical Display
FDA 510(k) K932724 · Spacelabs Medical, Inc.
510(k) numberK932724
Submission
- Device name
- Spacelabs Medical Integrated Clinical Display
- Applicant
- Spacelabs Medical, Inc.
Redmond, WA, US - Received
- June 7, 1993
- Decision date
- November 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K120616 | Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special | 03/29/2012SE |
| K112962 | Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)MHX · Special | 11/02/2011SE |
| K102422 | Spacelabs Medical Patient MonitorsMHX · Special | 12/07/2010SE |
| K093501 | Elance Vital Signs Monitor and Elance Central StationMHX · Special | 11/24/2009SE |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special | 08/01/2008SE |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional | 03/15/2007SE |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated | 09/29/2006SE |
| K062278 | Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special | 09/19/2006SE |
| K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional | 06/23/2006SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | 04/19/2006SE |
Questions and answers
When was Spacelabs Medical Integrated Clinical Display cleared by the FDA?
Spacelabs Medical Integrated Clinical Display (K932724) received a 510(k) decision of Substantially Equivalent on November 5, 1993, 151 days after the submission was received.
What is the product code of K932724?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.