Compax 90/15E
FDA 510(k) K954356 · General Electric Co.
510(k) numberK954356
Submission
- Device name
- Compax 90/15E
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- September 18, 1995
- Decision date
- October 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | Acoma Medical Imaging, Inc. | 01/23/1997SE |
| K961022 | Tangent Vi TableIXR · Traditional | Fischer Imaging Corp. | 05/03/1996SE |
| K953557 | Surgical C-Arm Table, 9610IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
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Questions and answers
When was Compax 90/15E cleared by the FDA?
Compax 90/15E (K954356) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 19 days after the submission was received.
What is the product code of K954356?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.