Dyna Glide 2600 Roll-In Ambulance Cot (95759)
FDA 510(k) K972528 · Dyna Corp.
510(k) numberK972528
Submission
- Device name
- Dyna Glide 2600 Roll-In Ambulance Cot (95759)
- Applicant
- Dyna Corp.
Carlsbad, CA, US - Received
- July 7, 1997
- Decision date
- July 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPO – Stretcher, Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6910
- Specialty
- General Hospital
Other 510(k)s with product code FPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113598 | Power-Load Cot Fastener SystemFPO · Traditional | Stryker Medical | 12/20/2011SE |
| K072598 | Irsg I-Mover for BedsFPO · Traditional | International Retail Services Group, LLC | 04/14/2008SE |
| K955766 | Adult-Pediatric Transport SystemFPO · Traditional | International Biomedical, Inc. | 08/07/1996SE |
| K962181 | Hare Model 2000 Ez Loader Model 95555FPO · Traditional | Dyna Corp. | 08/01/1996SE |
| K961437 | Wheeled StretcherFPO · Traditional | Hill-Rom, Inc. | 06/03/1996SE |
| K952447 | Hill-Rom Ambulatory Care Procedural StretcherFPO · Traditional | Hill-Rom, Inc. | 11/22/1995SE |
| K946101 | Emergency/Accident Trolley 550FPO · Traditional | Hogan & Hartson | 02/07/1995SE |
| K945431 | Model 792 Converge, Model 793 Vision 2000FPO · Traditional | Hausted, Inc. | 01/25/1995SE |
| K943969 | Model 578 Mobile Surgical StretcherFPO · Traditional | Hausted, Inc. | 01/25/1995SE |
| K942948 | Stryker Powered StretcherFPO · Traditional | Stryker Corp. | 01/24/1995SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962181 | Hare Model 2000 Ez Loader Model 95555FPO · Traditional | 08/01/1996SE |
| K902503 | Hare Folding Back Emergency StretcherFPO · Traditional | 06/26/1990SE |
| K900671 | Hare Emergency Stretcher with WheelsFPP · Traditional | 04/23/1990SE |
| K900670 | Hare Emergency StretcherFPP · Traditional | 04/23/1990SE |
Questions and answers
When was Dyna Glide 2600 Roll-In Ambulance Cot (95759) cleared by the FDA?
Dyna Glide 2600 Roll-In Ambulance Cot (95759) (K972528) received a 510(k) decision of Substantially Equivalent on July 28, 1997, 21 days after the submission was received.
What is the product code of K972528?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.