Identifiers
- 510(k) Number
- K812271 FDA 510(k)
- FDA Product Code
- DRT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Central Station Monitor is a Class II cardiac monitoring device designed to continuously observe and record cardiac activity. It functions as a cardiotachometer and rate alarm, providing real-time visualization and alerting capabilities for heart rate parameters in clinical settings. This device is intended for use in cardiovascular monitoring environments where continuous patient observation is critical.
The Central Station Monitor is supplied as a reusable medical device and is intended for use in hospital or clinical environments. It is regulated under FDA 510(k) clearance (K812271) with a classification under regulation number 870.2300. The device is not specified as MRI-safe or single-use, and no sterility requirements are noted in the available data. It operates within the product code category DRT and was reviewed by the Cardiovascular Advisory Committee.
Frequently asked questions
What is the Central Station Monitor used for?
The Central Station Monitor is designed for continuous cardiac monitoring in clinical settings, specifically to observe and record heart activity. It functions as a cardiotachometer and rate alarm, providing real-time visualization of heart rate parameters and alerting clinicians to abnormal rhythms. This is particularly useful in cardiovascular units where constant patient observation is essential.
Is the Central Station Monitor a single-use or reusable device?
The Central Station Monitor is supplied as a reusable medical device. It is intended for repeated use in hospital or clinical environments, rather than being discarded after a single use. This design allows for cost-effective monitoring over extended periods.
What regulatory approval does the Central Station Monitor hold?
The Central Station Monitor holds FDA 510(k) clearance under the classification number 870.2300. It was reviewed by the Cardiovascular Advisory Committee and determined to be substantially equivalent to a predicate device. The clearance number is K812271, and it falls under the product code category DRT.
Are there specific sterility requirements for the Central Station Monitor?
The available data does not specify any sterility requirements for the Central Station Monitor. Since it is a reusable device, it is likely intended to be cleaned and disinfected between uses rather than being sterile out-of-the-box. Always follow manufacturer guidelines for reprocessing.
What environments is the Central Station Monitor intended for?
The Central Station Monitor is intended for use in hospital or clinical environments where continuous cardiac monitoring is critical. This includes cardiovascular units, intensive care units, and other settings where real-time heart rate visualization and alarming are necessary for patient safety and clinical decision-making.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CENTRAL STATION MONITOR (K812271) - FDA 510 (k), CENTRAL STATION MONITOR (K812271) — FDA 510(k) | Innolitics, Datascope Central Station Monitor - allmed.wiki, Central Station Monitor 510 (k) K812271 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K812271 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K812271 24 fields · synced Oct 1, 2026