Patient Care Management System Modification
FDA 510(k) K910029 · Spacelabs, Inc.
510(k) numberK910029
Submission
- Device name
- Patient Care Management System Modification
- Applicant
- Spacelabs, Inc.
Redmond, WA, US - Received
- January 3, 1991
- Decision date
- January 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K031148 | In-Vision Imaging SystemDXK · Special | Jomed, Inc. | 05/28/2003SE |
| K934887 | 9750 Athena Ethernet OptionDXK · Traditional | S & W Medico Teknik A/S | 01/14/1994SE |
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| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
| K904832 | Modified Syst: Sonos 500/1000 Ultrsound Imag SystDXK · Traditional | Hewlett-Packard Co. | 04/22/1991SE |
| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | 05/31/1996SE |
| K951605 | Spacelabs Medical Casemaster Information Management SystemDSH · Traditional | 07/14/1995SE |
| K950779 | Heart Rate Variability Software OptionDPS · Traditional | 04/25/1995SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | 10/06/1994SE |
| K923788 | Space Labs Model 90560LOS · Traditional | 12/06/1993SE |
| K912742 | Esophageal Stethoscope Temperature ProbeFLL · Traditional | 04/20/1992SE |
| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
| K904318 | Local Report GeneratorDXN · Traditional | 12/18/1990SE |
Questions and answers
When was Patient Care Management System Modification cleared by the FDA?
Patient Care Management System Modification (K910029) received a 510(k) decision of Substantially Equivalent on January 31, 1991, 28 days after the submission was received.
What is the product code of K910029?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.