Tec 2750 Phoenix Dedicated Mammographic System
FDA 510(k) K892342 · Bay Shore Medical Equipment Corp.
510(k) numberK892342
Submission
- Device name
- Tec 2750 Phoenix Dedicated Mammographic System
- Applicant
- Bay Shore Medical Equipment Corp.
Bay Shore, NY, US - Received
- April 5, 1989
- Decision date
- November 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Tec 2750 Phoenix Dedicated Mammographic System cleared by the FDA?
Tec 2750 Phoenix Dedicated Mammographic System (K892342) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 226 days after the submission was received.
What is the product code of K892342?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.