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Patient Monitor Model 405P

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955546

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K955546 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Patient Monitor Model 405P is a physiological monitoring device classified as a Patient Monitor, designed to track and display vital signs for patient assessment. It provides real-time cardiac gating signals to synchronize imaging modalities such as nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT).

This device is intended for use in clinical settings where continuous patient monitoring is required, such as radiology departments or cardiac care units. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure accurate performance. The Model 405P holds an FDA 510(k) clearance (K955546) under the Product Code DPS, with a decision date of August 16, 1996, and is substantially equivalent to the previously approved Model 405T.

Frequently asked questions

What clinical environments is the Patient Monitor Model 405P primarily intended for use in, and why?

The Patient Monitor Model 405P is designed for clinical settings where continuous patient monitoring is essential, such as radiology departments or cardiac care units. This is because it provides real-time cardiac gating signals, which synchronize imaging modalities like CT, MR, PET, and SPECT—critical for accurate diagnostic imaging in these specialized areas.

Is the Patient Monitor Model 405P a single-use or reusable device, and what does this mean for maintenance?

The Patient Monitor Model 405P is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it requires calibration to ensure accuracy, facilities must follow manufacturer guidelines for servicing to maintain performance and compliance with clinical standards.

How does the FDA classify the Patient Monitor Model 405P, and what does this classification imply about its regulatory status?

The Patient Monitor Model 405P holds an FDA 510(k) clearance under Product Code DPS, with a decision of *substantially equivalent* to the previously approved Model 405T. This classification means the FDA determined it poses the same risk profile as the predecessor device and is therefore cleared for commercial distribution in the U.S. without further approval steps.

What types of imaging modalities can the Model 405P synchronize with, and why is this feature important?

The Model 405P provides real-time cardiac gating signals to synchronize imaging modalities such as nuclear medicine, CT, MR, PET, and SPECT. This synchronization is important because it ensures imaging data aligns with the patient’s heartbeat, improving diagnostic accuracy—especially in cardiac and vascular studies where precise timing is critical.

Who is the manufacturer of the Patient Monitor Model 405P, and where can inquiries about the device be directed?

The manufacturer of the Patient Monitor Model 405P is Ivy Biomedical Systems, Inc., based in Branford, Connecticut. For inquiries, contact details such as the address (11 Business Park Dr., Branford, CT 06405) and a named contact (Dick Listro) are available in the regulatory filing. Reach out directly to the manufacturer for technical support or maintenance questions.

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: PATIENT MONITOR MODEL 405P by IVY BIOMEDICAL SYSTEMS, INC. | FDA 510 (k ..., PATIENT MONITOR MODEL 405P (K955546) — FDA 510(k) | Innolitics, Patient Monitor Model 405p - Beudamed, K904606 FDA 510(k) - MODEL 405 | Ivy Biomedical Systems, Inc.

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) K955546 24 fields · synced Sep 18, 2026