Model 792 Converge, Model 793 Vision 2000
FDA 510(k) K945431 · Hausted, Inc.
510(k) numberK945431
Submission
- Device name
- Model 792 Converge, Model 793 Vision 2000
- Applicant
- Hausted, Inc.
Medina, OH, US - Received
- August 15, 1994
- Decision date
- January 25, 1995
- 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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More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K943969 | Model 578 Mobile Surgical StretcherFPO · Traditional | 01/25/1995SE |
Questions and answers
When was Model 792 Converge, Model 793 Vision 2000 cleared by the FDA?
Model 792 Converge, Model 793 Vision 2000 (K945431) received a 510(k) decision of Substantially Equivalent on January 25, 1995, 163 days after the submission was received.
What is the product code of K945431?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.