Physiological Monitor Model 3000 (Series)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023616 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)
This device is a Cardiac (Incl. Cardiotachometer & Rate Alarm) Monitor, designed to measure and display physiological parameters such as heart rate and rhythm. It synchronizes radiographic imaging acquisition across modalities like nuclear medicine, computed tomography, and magnetic resonance imaging (MRI).
The Physiological Monitor Model 3000 (Series) is intended for use in clinical settings, including radiology and nuclear medicine departments. It is a reusable device, not single-use, and is classified as Class II under FDA regulations. The monitor has received FDA 510K clearance under the Special 510(k) pathway and complies with the European Medical Device Directive 93/42/EEC when used as instructed. No specific MRI safety classification is stated in the provided data.
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: PDF Model 3000 Series OPERATION MANUAL - Ivy Biomedical Systems, Ivy Biomedical Systems 3000 Series Operation Manual, Ivy Biomedical Systems 3000 Series Service Manual, PDF Ivy 3000 Series Operation Manual.pdf - iFixit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023616 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K023616 24 fields · synced Sep 18, 2026