Hill-Rom Patient Environmental Control System
FDA 510(k) K921528 · Hill-Rom, Inc.
510(k) numberK921528
Submission
- Device name
- Hill-Rom Patient Environmental Control System
- Applicant
- Hill-Rom, Inc.
Batesville, TN, US - Received
- April 2, 1992
- Decision date
- April 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IQA – System, Environmental Control, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3725
- Specialty
- Physical Medicine
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| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
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Questions and answers
When was Hill-Rom Patient Environmental Control System cleared by the FDA?
Hill-Rom Patient Environmental Control System (K921528) received a 510(k) decision of Substantially Equivalent on April 20, 1992, 18 days after the submission was received.
What is the product code of K921528?
The FDA product code is IQA – System, Environmental Control, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3725.