Mevatron, M 2 Class
FDA 510(k) K882729 · Siemens Medical Laboratories, Inc.
510(k) numberK882729
Submission
- Device name
- Mevatron, M 2 Class
- Applicant
- Siemens Medical Laboratories, Inc.
Walnut Creek, CA, US - Received
- July 6, 1988
- Decision date
- September 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mevatron, M 2 Class cleared by the FDA?
Mevatron, M 2 Class (K882729) received a 510(k) decision of Substantially Equivalent on September 19, 1988, 75 days after the submission was received.
What is the product code of K882729?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.