Tec 2720 Mamex DC Mag
FDA 510(k) K854203 · Tecnomed, Inc.
510(k) numberK854203
Submission
- Device name
- Tec 2720 Mamex DC Mag
- Applicant
- Tecnomed, Inc.
Bay Shore, NY, US - Received
- October 16, 1985
- Decision date
- March 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Tec 2720 Mamex DC Mag cleared by the FDA?
Tec 2720 Mamex DC Mag (K854203) received a 510(k) decision of Substantially Equivalent on March 6, 1986, 141 days after the submission was received.
What is the product code of K854203?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.