Telemetry Monitor 5500 Release 4.0 (867232)
FDA 510(k) K242962 · Philips Medizin Systeme Böblingen GmbH
510(k) numberK242962
Submission
- Device name
- Telemetry Monitor 5500 Release 4.0 (867232)
- Applicant
- Philips Medizin Systeme Böblingen GmbH
Böblingen, DE - Received
- September 25, 2024
- Decision date
- May 5, 2025
- 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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| 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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| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…MHX · Traditional | 11/10/2025SE |
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| K241890 | Philips Holter Analysis SystemMLO · Traditional | 03/21/2025SE |
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| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)MHX · Traditional | 02/03/2023SE |
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Questions and answers
When was Telemetry Monitor 5500 Release 4.0 (867232) cleared by the FDA?
Telemetry Monitor 5500 Release 4.0 (867232) (K242962) received a 510(k) decision of Substantially Equivalent on May 5, 2025, 222 days after the submission was received.
What is the product code of K242962?
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.