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Model 405t With Etco2 Option

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964961

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K964961 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model 405T with ETCO₂ Option is a cardiac gating monitor designed for synchronizing radiographic image acquisition across imaging modalities, including nuclear medicine, computed tomography, magnetic resonance, positron emission tomography, and single photon emission computed tomography. It provides real-time monitoring of patient respiration and cardiac activity to ensure precise timing of image capture, improving diagnostic accuracy in dynamic studies.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as radiology and nuclear medicine departments. It includes an ETCO₂ (end-tidal carbon dioxide) measurement capability for enhanced respiratory monitoring. The Model 405T with ETCO₂ Option holds an FDA 510(k) clearance (K964961) under the product code CCK, classified as substantially equivalent to a predicate device, and is regulated under the Anesthesiology advisory committee classification.

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: MODEL 405T WITH ETCO2 OPTION (K964961) — FDA 510(k) | Innolitics, Process Reference Model Process Assessment Model - VDA QMC, Model 405t With Etco2 Option - Beudamed, MODEL 405T WITH ETCO2 OPTION 510 (k) K964961 - FDA.report, FDA Browser - Cleared 510 (K) - MODEL 405T WITH ETCO2 OPTION (K964961)

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) K964961 24 fields · synced Sep 18, 2026