Disposable Diaphragm Domes
FDA 510(k)Class II (US FDA 510(k))
by Medex, Inc.
Identifiers
- 510(k) Number
- K820355 FDA 510(k)
- FDA Product Code
- DRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2850 FDA 510(k)
- Regulation Number
- 870.2850 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable Diaphragm Domes are extravascular blood pressure transducers designed for clinical monitoring applications. These devices function by converting physiological pressure signals into electrical signals for accurate measurement.
This device is supplied as a single-use component and is subject to FDA 510(k) clearance under the regulation number 870.2850. It is manufactured by Medex, Inc. and is intended for use within cardiovascular clinical settings.
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: DISPOSABLE DIAPHRAGM DOME (K810009) — FDA 510(k) | Innolitics, DISPOSABLE DIAPHRAGM DOMES (K820355) — FDA 510(k) | Innolitics, DISPOSABLE DIAPHRAGM DOMES 510 (k) K820355 - FDA.report, PDF K820355 - Disposable Diaphragm Domes, MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX DISPOSABLE ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K820355 | Class II | Active |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K820355 24 fields · synced Sep 24, 2026