Unity Is Patient Viewer
FDA 510(k) K020661 · General Electric Medical Systems Information Techn
510(k) numberK020661
Submission
- Device name
- Unity Is Patient Viewer
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- March 1, 2002
- Decision date
- May 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023380 | T-Wave Altermans (Twa) Algorithm OptionDQK · Traditional | 12/03/2002SE |
| K021470 | Seer Light Compact Digital Holter RecorderMWJ · Traditional | 11/14/2002SE |
| K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsLLZ · Special | 10/11/2002SE |
| K021454 | Unity Network IdMWI · Traditional | 10/01/2002SE |
| K020290 | Dash 3000/4000 Patient MonitorMHX · Traditional | 08/14/2002SE |
| K021366 | Mac-Lab/Cardiolab Ep/CombolabDQK · Special | 07/03/2002SE |
| K021325 | Modification of Apexpro Telemetry SystemMHX · Special | 05/07/2002SE |
| K020524 | Patientnet Monitoring SystemMSX · Special | 03/20/2002SE |
| K012467 | Solar 8000M SystemDSI · Traditional | 02/11/2002SE |
| K014108 | Mac 5000 ECG Analysis SystemDQK · Special | 01/10/2002SE |
Questions and answers
When was Unity Is Patient Viewer cleared by the FDA?
Unity Is Patient Viewer (K020661) received a 510(k) decision of Substantially Equivalent on May 24, 2002, 84 days after the submission was received.
What is the product code of K020661?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.