Model D-285N Administration Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954841 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model D-285n Administration Set is a medical device used for the delivery of fluids. It is designed to facilitate the administration of intravenous solutions to patients in a clinical setting.
This device is regulated under FDA 510(k) clearance, identified by K-number K954841. It is classified under regulation number 880.5440 within the General Hospital medical specialty.
Frequently asked questions
What is the primary function of the Model D-285n Administration Set?
The Model D-285n is designed to facilitate the delivery of intravenous solutions to patients. It serves as a medical device for fluid administration within a clinical environment.
What is the regulatory status of this administration set?
This device is regulated under FDA 510(k) clearance, identified by K-number K954841. It is classified under regulation number 880.5440 within the General Hospital medical specialty.
Which medical specialty is this device associated with?
The Model D-285n Administration Set is categorized under the General Hospital medical specialty, as indicated by its regulatory classification and advisory committee designation.
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 D-285n Administration Set 510 (k) FDA Premarket Notification ..., Model D-285n Administration Set - Beudamed, Patient Solutions, Inc. · DeviceClearance, Patient Solutions Inc FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954841 | Class II | Active |
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Manufacturer
- Manufacturer
- Patient Solutions, Inc.
Sources (1)
- FDA 510(k) K954841 24 fields · synced Sep 21, 2026