Micro-Fine High Freq. Mobile Mammo. System MF-150
FDA 510(k) K885135 · Bennett X-Ray Corp.
510(k) numberK885135
Submission
- Device name
- Micro-Fine High Freq. Mobile Mammo. System MF-150
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- December 15, 1988
- Decision date
- March 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Micro-Fine High Freq. Mobile Mammo. System MF-150 cleared by the FDA?
Micro-Fine High Freq. Mobile Mammo. System MF-150 (K885135) received a 510(k) decision of Substantially Equivalent on March 9, 1989, 84 days after the submission was received.
What is the product code of K885135?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.