Witt Biomedical Series Ii-Ep
FDA 510(k) K923054 · Witt Biomedical Corporation
510(k) numberK923054
Submission
- Device name
- Witt Biomedical Series Ii-Ep
- Applicant
- Witt Biomedical Corporation
Melbourne, FL, US - Received
- June 24, 1992
- Decision date
- February 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
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|---|---|---|---|
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| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
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| K063840 | Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care…MWI · Traditional | 02/06/2007SE |
| K063547 | Calysto Series IV Physio-Monitoring and Information SystemMWI · Special | 12/21/2006SE |
| K040195 | Calysto Image Iv-Image and Information Management SystemLLZ · Traditional | 04/07/2004SE |
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| K010058 | Image IV Dicom Image Archival Pacs NetworkLLZ · Traditional | 03/21/2001SE |
| K973474 | Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient…MHX · Traditional | 03/13/1998SE |
| K950436 | Witt Biomedical Series IVMHX · Traditional | 11/02/1995SE |
| K945582 | Witt Biomedical Image IIILLZ · Traditional | 06/19/1995SE |
| K880258 | Witt Biomedical VX-80DXG · Traditional | 06/16/1988SE |
Questions and answers
When was Witt Biomedical Series Ii-Ep cleared by the FDA?
Witt Biomedical Series Ii-Ep (K923054) received a 510(k) decision of Substantially Equivalent on February 25, 1993, 246 days after the submission was received.
What is the product code of K923054?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.