Alarmview Wireless Data Network System
FDA 510(k) K010912 · Data Critical Corp.
510(k) numberK010912
Submission
- Device name
- Alarmview Wireless Data Network System
- Applicant
- Data Critical Corp.
Bothell, WA, US - Received
- March 27, 2001
- Decision date
- April 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
| 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 |
| K962473 | (Vcom, Irvs, RVS) Central Monitoring Station, V-Link or Ambulatory Transmitters and…MSX · Traditional | 11/06/1997ST |
Questions and answers
When was Alarmview Wireless Data Network System cleared by the FDA?
Alarmview Wireless Data Network System (K010912) received a 510(k) decision of Substantially Equivalent on April 5, 2001, 9 days after the submission was received.
What is the product code of K010912?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.