Modification to Bernoulli Ventilator Management System Software
FDA 510(k) K051283 · Cardiopulmonary Corp.
510(k) numberK051283
Submission
- Device name
- Modification to Bernoulli Ventilator Management System Software
- Applicant
- Cardiopulmonary Corp.
Milford, CT, US - Received
- May 17, 2005
- Decision date
- June 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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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 |
|---|---|---|
| K130208 | Bernoulli Enterprise SoftwareMHX · Traditional | 12/20/2013SE |
| K091461 | Bernoulli Management System, Oxinet III and Lifegard VueMOD · Traditional | 08/14/2009SE |
| K061932 | Bernoulli Management System (MS) SoftwareMSX · Traditional | 09/14/2006SE |
| K020018 | Modification to Bernoulli Ventilator Management System SoftwareMSX · Traditional | 02/21/2002SE |
| K011861 | Bernoulli Ventilator Management SystemMOD · Traditional | 11/06/2001SE |
| K990429 | Modification of Venturi VentilatorCBK · Special | 02/24/1999ST |
| K982174 | Venturi VentilatorCBK · Traditional | 06/24/1998ST |
| K943412 | Venturi VentilatorCBK · Traditional | 10/16/1995ST |
Questions and answers
When was Modification to Bernoulli Ventilator Management System Software cleared by the FDA?
Modification to Bernoulli Ventilator Management System Software (K051283) received a 510(k) decision of Substantially Equivalent on June 23, 2005, 37 days after the submission was received.
What is the product code of K051283?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.