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Patient Monitor Model 701

FDA 510(k)

Class II (US FDA 510(k))

510(k) K884096

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K884096 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 Patient Monitor Model 701 is a cardiac patient monitor designed for real-time monitoring of heart rate and rhythm. Classified as a cardiac monitor (including cardiotachometer and rate alarm), it is intended for continuous assessment of cardiac activity in clinical settings.

This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the classification DRT (Diagnostic Radiology). It is intended for use in environments requiring precise cardiac synchronization for imaging procedures, such as nuclear medicine, CT, MRI, PET, and SPECT. No specific sterility or MRI safety details are provided in the regulatory data.

Frequently asked questions

What clinical settings is the Patient Monitor Model 701 primarily designed for, and how does it support those environments?

The Patient Monitor Model 701 is designed for continuous real-time monitoring of heart rate and rhythm in clinical settings. It is particularly useful in environments requiring precise cardiac synchronization for imaging procedures, such as nuclear medicine, CT, MRI, PET, and SPECT scans. This ensures accurate monitoring of cardiac activity during these procedures, helping to maintain patient safety and synchronization with imaging equipment.

Is the Patient Monitor Model 701 intended for single-use or reusable applications, and what does this mean for maintenance and cleaning?

The Patient Monitor Model 701 is supplied as a reusable medical instrument. This means it is designed to be cleaned, disinfected, and reused multiple times under proper clinical protocols. Reusability helps reduce waste and costs, but it also requires adherence to strict cleaning and maintenance procedures to ensure reliability and patient safety.

What regulatory pathway was followed for FDA clearance of the Patient Monitor Model 701, and what does this imply about its safety and performance?

The Patient Monitor Model 701 received FDA 510(k) clearance under the classification for diagnostic radiology (DRT) and was determined to be substantially equivalent to a predicate device. This traditional clearance pathway involves a review by the FDA’s Cardiovascular Advisory Committee, ensuring that the device meets established safety and performance standards for cardiac monitoring. The clearance implies that the device has been evaluated for compliance with applicable regulations, including its intended use for continuous cardiac monitoring.

Are there any specific storage requirements or considerations for the Patient Monitor Model 701?

The provided regulatory data does not specify any unique sterility or storage requirements for the Patient Monitor Model 701 beyond standard practices for reusable medical devices. Since it is reusable, it should be stored in a clean, dry environment, protected from physical damage and contamination, to maintain its functionality and ensure readiness for use. Always follow manufacturer guidelines for storage and handling to preserve device integrity.

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: K884096 FDA 510 (k) - PATIENT MONITOR MODEL 701, PATIENT MONITOR MODEL 701 (K884096) — FDA 510(k) | Innolitics, PDF K884096 PATIENT MONITOR MODEL 701 - 510kdatabase.net, Ivy Biomedical System Inc 701 Patient Monitor - eBay, Patient Monitor Model 701 510 (k) FDA Premarket Notification K884096 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K884096 24 fields · synced Sep 18, 2026