Mortara Surveyor Telemetry Central Station
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060135 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mortara Surveyor Telemetry Central Station is a patient central monitoring system designed for the centralized monitoring of electrocardiogram (ECG) signals from hospital patients. It receives and processes telemetry data transmitted by compatible transmitters, including the Mortara X12 Ambulatory Telemetry Transmitter, to provide continuous physiological monitoring. The device functions as a central hub for displaying and managing real-time ECG data across connected monitoring stations.
This device is intended for use in clinical settings such as hospitals and healthcare facilities for patient monitoring. It is supplied as a central system unit and operates in conjunction with compatible telemetry transmitters. The device is regulated under FDA 510(k) regulations and is classified as a Class II physiological patient monitor. Storage and handling should follow standard medical equipment guidelines, and specific operational details are provided in the manufacturer's user manual.
Frequently asked questions
What is the Mortara Surveyor Telemetry Central Station used for?
It is designed for the centralized monitoring of electrocardiogram (ECG) signals from hospital patients, receiving and processing telemetry data from compatible transmitters to provide continuous physiological monitoring across connected stations.
How is the Mortara Surveyor Telemetry Central Station supplied and what does it require to operate?
It is supplied as a central system unit and requires compatible telemetry transmitters, such as the Mortara X12 Ambulatory Telemetry Transmitter, to receive and process patient ECG data for monitoring.
Is the Mortara Surveyor Telemetry Central Station intended for single-use or reuse, and where is it used?
It is intended for reuse in clinical settings such as hospitals and healthcare facilities, serving as a central hub for displaying and managing real-time ECG data from multiple patients.
What regulatory pathway was used for the Mortara Surveyor Telemetry Central Station?
The device is regulated under FDA 510(k) regulations, with clearance based on substantial equivalence to a predicate device, and is classified as a Class II physiological patient monitor.
What storage and handling guidelines apply to the Mortara Surveyor Telemetry Central Station?
Storage and handling should follow standard medical equipment guidelines, with specific operational details provided in the manufacturer's user manual to ensure proper function and longevity.
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: MORTARA SURVEYOR USER MANUAL Pdf Download | ManualsLib, Mortara Surveyor Manuals | ManualsLib, MORTARA SURVEYOR TELEMETRY CENTRAL STATION (K060135) — FDA 510 (k ..., Patient central monitoring station Surveyor™ Central Mortara
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060135 | Class II | Active |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (1)
- FDA 510(k) K060135 24 fields · synced Sep 28, 2026