Argus PB-3000
FDA 510(k) K221056 · Schiller AG
510(k) numberK221056
Submission
- Device name
- Argus PB-3000
- Applicant
- Schiller AG
Baar, CH - Received
- April 11, 2022
- Decision date
- July 6, 2023
- 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
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| 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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| K101619 | Welch Allyn 1500 Patient MonitorMHX · Traditional | 11/12/2010SE |
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| K053207 | Argus, Model LCMMHX · Traditional | 05/19/2006SE |
| K051368 | BR 102 Plus Blood Pressure Holter SystemDXN · Traditional | 08/09/2005SE |
| K050686 | Cardiovit AT-10PLUSDPS · Traditional | 05/04/2005SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | 08/24/2004SE |
Questions and answers
When was Argus PB-3000 cleared by the FDA?
Argus PB-3000 (K221056) received a 510(k) decision of Substantially Equivalent on July 6, 2023, 451 days after the submission was received.
What is the product code of K221056?
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.