MSX — System, Network And Communication, Physiological Monitors Class II
FDA product code MSX covers "System, Network And Communication, Physiological Monitors", a Class II medical device regulated under 21 CFR 870.2300. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MSX
- Device Class
- Class II
- Regulation Number
- 870.2300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253654 | philips medizin systeme böblingen | IntelliVue Measurement Rack 6000 (867317) | March 30, 2026 |
| K243270 | tigerconnect | TigerConnect Alarm Management | September 30, 2025 |
| K242728 | shenzhen mindray bio-medical electronics co | BeneVision Central Monitoring System | July 31, 2025 |
| K242750 | nihon kohden digital health solutions | Central Station | June 5, 2025 |
| K242842 | sibel health | ANNE View, Central Hub | January 8, 2025 |
| K241397 | hinlab | Hinscope | November 14, 2024 |
| K233834 | draeger medical systems | Infinity Gateway Suite | July 12, 2024 |
| K233418 | biofourmis singapore pte | Biofourmis Everion+ (G2) | May 9, 2024 |
| K232548 | corsano health | Corsano CardioWatch 287-2 System | March 22, 2024 |
| K231506 | current health | Current Health System | August 24, 2023 |
| K223567 | nihon kohden corporation | CNS-2101 Central Monitor | July 31, 2023 |
| K213863 | biofourmis singapore pte | Everion+ System | February 23, 2023 |
| K222550 | current health | Current Health System | November 1, 2022 |
| K203579 | draeger medical systems | Infinity Gateway Suite | June 7, 2022 |
| K211046 | visicu | eCareManager 4.5 | June 3, 2022 |
| K220058 | shenzhen mindray bio-medical electronics co | BeneVision Central Monitoring System | June 1, 2022 |
| K212622 | zyter | Zyter RPM | February 11, 2022 |
| K211949 | airstrip technologies | AirStrip ONE Web Client with Alarm Communication Management (ACM) | December 9, 2021 |
| K210160 | alertwatch | AlertWatch:AC | September 10, 2021 |
| K210133 | current health | Current Health Monitoring System Gen 2 (G2) | September 3, 2021 |