Model 702 ECG/Respiration/Temperature - Temperature
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K884455 FDA 510(k)
- FDA Product Code
- DRT FDA 510(k)
- Models / Variants
- 702 Ecg FDA 510(k)Respiration FDA 510(k)Temperature 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 Model 702 ECG/Respiration/Temperature is a cardiac monitor designed to measure and display electrocardiographic (ECG) signals, respiration rate, and body temperature. It falls under the classification of a cardiac monitor, including cardiotachometers and rate alarms, and is intended for use in cardiovascular monitoring applications.
This device is supplied as a reusable medical instrument and is classified as a Class II device under FDA regulations (870.2300). It was granted FDA 510(k) clearance (K884455) in 1989, with a decision of Substantially Equivalent under the Cardiovascular advisory committee. The device is intended for use in clinical settings where continuous monitoring of cardiac, respiratory, and temperature parameters is required, such as during radiographic imaging procedures.
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 702 ECG/RESPIRATION/TEMPERATURE - Innolitics, Ivy Biomedical 702 Ecg/respiration/temperature - allmed.wiki, PDF K884455 - Model 702 Ecg/Respiration/Temperature, Model 702 Ecg/respiration/temperature 510 (k) FDA Premarket ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884455 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K884455 24 fields · synced Sep 18, 2026