Masimo Patient Safety Net
FDA 510(k) K071047 · Masimo Corporation
510(k) numberK071047
Submission
- Device name
- Masimo Patient Safety Net
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- April 13, 2007
- Decision date
- June 8, 2007
- 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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| 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 |
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| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | 07/17/2025SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
Questions and answers
When was Masimo Patient Safety Net cleared by the FDA?
Masimo Patient Safety Net (K071047) received a 510(k) decision of Substantially Equivalent on June 8, 2007, 56 days after the submission was received.
What is the product code of K071047?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.