MAMMI
K-Number: K161631 · 2016-07-28
Decision Date2016-07-28
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MAMMI is a medical device manufactured by General Equipment For Medical Imaging. It received FDA 510(k) clearance on 2016-07-28 under approval number K161631. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MAMMI?
MAMMI is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by General Equipment For Medical Imaging. The 510(k) number is K161631.
When was MAMMI approved by the FDA?
MAMMI received FDA 510(k) clearance on 2016-07-28, under approval number K161631.
What company makes MAMMI?
MAMMI is manufactured by General Equipment For Medical Imaging.
What is the FDA product code for MAMMI?
The FDA product code for MAMMI is KPS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.