Non-Magnetic Examination Table for Magnetic Resona
FDA 510(k) K844578 · Engineering Dynamics Corp.
510(k) numberK844578
Submission
- Device name
- Non-Magnetic Examination Table for Magnetic Resona
- Applicant
- Engineering Dynamics Corp.
Lowell, MA, US - Received
- November 23, 1984
- Decision date
- May 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Decision |
|---|---|---|
| K871494 | Uppercycle Stationary Exercise MachinesISD · Traditional | 05/06/1987SE |
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| K834098 | Stationary Exercise BicycleISD · Traditional | 12/27/1983SE |
| K828313 | Digital Radiography Examination Table · Traditional | 10/07/1982SE |
| K802254 | General Ultrasound Exam. TableIYN · Traditional | 11/26/1980SE |
| K790545 | Stress Testing System, Lateral TiltingDRT · Traditional | 06/06/1979SE |
| K790544 | Stress Testing System, Multi-PositionDRT · Traditional | 06/05/1979SE |
| K790466 | U-MatIYX · Traditional | 03/28/1979SE |
| K790499 | Multiple Pinhole Tomographic CollimoterIYX · Traditional | 03/26/1979SE |
Questions and answers
When was Non-Magnetic Examination Table for Magnetic Resona cleared by the FDA?
Non-Magnetic Examination Table for Magnetic Resona (K844578) received a 510(k) decision of Substantially Equivalent on May 14, 1985, 172 days after the submission was received.
What is the product code of K844578?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.