(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with
FDA 510(k) K962473 · Data Critical Corporation
510(k) numberK962473
Submission
- Device name
- (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with
- Applicant
- Data Critical Corporation
Tustin, CA, US - Received
- June 25, 1996
- Decision date
- November 6, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code MSX
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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 |
|---|---|---|
| K013156 | Modification to Alarmview Wireless Data Network SystemMSX · Special | 10/19/2001SE |
| K012005 | Modification to Alarmview Wireless Data Network SystemMSX · Special | 07/24/2001SE |
| K011999 | Modification to Flexview Clinical Monitoring SystemMSX · Special | 07/24/2001SE |
| K011436 | Mobile-Patient ViewerDPS · Traditional | 07/05/2001SE |
| K010912 | Alarmview Wireless Data Network SystemMSX · Special | 04/05/2001SE |
| K003998 | Flexview Clinical Monitoring SystemMSX · Special | 03/07/2001SE |
| K992848 | Alarmview SystemMSX · Traditional | 11/19/1999SE |
| K990378 | Statview SystemMSX · Traditional | 09/20/1999SE |
| K973527 | Cardio-Pager SystemMSX · Traditional | 03/31/1998SE |
| K971650 | Rhythmstat XLDXH · Traditional | 12/04/1997SE |
Questions and answers
When was (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with cleared by the FDA?
(Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and Arrhytmia Detector and Alarms with (K962473) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 6, 1997, 499 days after the submission was received.
What is the product code of K962473?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.