Wheeled Stretcher
FDA 510(k) K961437 · Hill-Rom, Inc.
510(k) numberK961437
Submission
- Device name
- Wheeled Stretcher
- Applicant
- Hill-Rom, Inc.
Batesville, IN, US - Received
- April 15, 1996
- Decision date
- June 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPO – Stretcher, Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6910
- Specialty
- General Hospital
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Questions and answers
When was Wheeled Stretcher cleared by the FDA?
Wheeled Stretcher (K961437) received a 510(k) decision of Substantially Equivalent on June 3, 1996, 49 days after the submission was received.
What is the product code of K961437?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.