Siemens Sireskop 4
FDA 510(k) K820111 · Siemens Corp.
510(k) numberK820111
Submission
- Device name
- Siemens Sireskop 4
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- January 15, 1982
- Decision date
- February 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | Continental X-Ray Corp. | 06/14/1993SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | Nucletron-Oldelft Corp. | 03/31/1993SE |
| K922098 | CAG-02AKXJ · Traditional | Toshiba America Medical Systems, In.C | 07/27/1992SE |
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Questions and answers
When was Siemens Sireskop 4 cleared by the FDA?
Siemens Sireskop 4 (K820111) received a 510(k) decision of Substantially Equivalent on February 18, 1982, 34 days after the submission was received.
What is the product code of K820111?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.