Mamex DC MG11
FDA 510(k) K881505 · Orion Corp.
510(k) numberK881505
Submission
- Device name
- Mamex DC MG11
- Applicant
- Orion Corp.
Conroe, TX, US - Received
- April 11, 1988
- Decision date
- June 10, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mamex DC MG11 cleared by the FDA?
Mamex DC MG11 (K881505) received a 510(k) decision of Substantially Equivalent on June 10, 1988, 60 days after the submission was received.
What is the product code of K881505?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.