Mevatron KD-2
FDA 510(k) K862339 · Siemens Medical Laboratories, Inc.
510(k) numberK862339
Submission
- Device name
- Mevatron KD-2
- Applicant
- Siemens Medical Laboratories, Inc.
Walnut Creek, CA, US - Received
- June 20, 1986
- Decision date
- October 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K812032 | Mevatron 67EIYE · Traditional | 08/18/1981SE |
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Questions and answers
When was Mevatron KD-2 cleared by the FDA?
Mevatron KD-2 (K862339) received a 510(k) decision of Substantially Equivalent on October 29, 1986, 131 days after the submission was received.
What is the product code of K862339?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.