PMP4 Application
FDA 510(k) K061428 · Card Guard Scientific Survival , Ltd.
510(k) numberK061428
Submission
- Device name
- PMP4 Application
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- May 23, 2006
- Decision date
- October 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code MSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K111745 | King of Hearts Express Af Cardiac Event RecorderDSH · Special | 08/01/2011SE |
| K110499 | CG-5108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Special | 04/06/2011SE |
| K101703 | Modification to: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Model…DSI · Special | 07/13/2010SE |
| K101639 | CG-6108 Act-Il Continuous ECG Monitor and Arrythmia DetectorDSI · Special | 06/25/2010SE |
| K083174 | HealthepodDXH · Traditional | 12/17/2009SE |
| K082521 | EASY2CHECK Blood Glucose and Blood Pressure Monitoring SystemNBW · Traditional | 01/16/2009SE |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | 05/29/2008SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | 12/18/2007SE |
| K061528 | Selfcheck GlucoCGA · Traditional | 09/22/2006SE |
| K060911 | CG-6108 Arrhythmia ECG Event RecorderDXH · Special | 08/22/2006SE |
Questions and answers
When was PMP4 Application cleared by the FDA?
PMP4 Application (K061428) received a 510(k) decision of Substantially Equivalent on October 16, 2006, 146 days after the submission was received.
What is the product code of K061428?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.