MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class II
FDA product code MHX covers "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", a Class II medical device regulated under 21 CFR 870.1025. 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
- MHX
- Device Class
- Class II
- Regulation Number
- 870.1025
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260656 | ge healthcare finland | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal | September 1, 2026 |
| K260343 | ge healthcare finland | Carescape Canvas 1000; Carescape Canvas Smart Display | August 28, 2026 |
| K260579 | draeger medical systems | Infinity® Acute Care System (IACS) VG8.1 | August 20, 2026 |
| K251508 | edan instruments | Telemetry Monitor (iT30, iT50) | August 6, 2026 |
| K253277 | ge medical systems information technologies | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | July 24, 2026 |
| K254209 | masimo corporation | Radius VSM and Accessories | June 4, 2026 |
| K252840 | global instrumentation | M12 Telemetry System | May 29, 2026 |
| K260098 | shenzhen mindray bio-medical electronics co | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A | May 20, 2026 |
| K250349 | shanghai draeger medical instrument co | Vista CMS | April 24, 2026 |
| K253170 | shenzhen mindray bio-medical electronics co | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | April 16, 2026 |
| K252250 | shanghai draeger medical instrument co | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasi | April 10, 2026 |
| K252726 | philips medizin systeme boeblingen | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 | February 6, 2026 |
| K252589 | alivecor | Corvair Monza | January 9, 2026 |
| K250854 | shenzhen comen medical instruments co | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); | December 17, 2025 |
| K251702 | philips medizin systeme böblingen | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 | November 10, 2025 |
| K251146 | philips medizin systeme boeblingen | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | October 17, 2025 |
| K250453 | philips medizin systeme böblingen | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); | September 2, 2025 |
| K250179 | edan instruments | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | July 29, 2025 |
| K242562 | ge medical systems information technologies | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | July 9, 2025 |
| K250757 | masimo corporation | Radius VSM and Accessories | May 29, 2025 |