Critical Care Hospital Bed (ICU/CCU)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K915437 FDA 510(k)
- FDA Product Code
- FNL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5100 FDA 510(k)
- Regulation Number
- 880.5100 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A critical care hospital bed (ICU/CCU) is a medical device designed for use in intensive care and coronary care units to support patient positioning, monitoring, and treatment during critical illness. It is substantially equivalent to a legally marketed predicate device and received traditional 510(k) clearance from the FDA under product code FNL.
The device is supplied by Hill-Rom, Inc. and is intended for use in general hospital settings. It is not sterile, not single-use, and has no stated MRI safety specifications. Storage and handling should follow manufacturer guidelines. The device was cleared under K915437 on June 11, 1992, and is authorized for distribution in the United States.
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: Home - Critical Care - Sauerstofftherapie, Schlaftherapie und …
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K915437 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA 510(k) K915437 24 fields · synced Sep 21, 2026