DenSeeMammo
K-Number: K173574 · 2018-06-26
ApplicantStatlife
Decision Date2018-06-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DenSeeMammo is a medical device manufactured by Statlife. It received FDA 510(k) clearance on 2018-06-26 under approval number K173574. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DenSeeMammo?
DenSeeMammo is a medical device that received FDA 510(k) clearance on 2018-06-26. It is manufactured by Statlife. The 510(k) number is K173574.
When was DenSeeMammo approved by the FDA?
DenSeeMammo received FDA 510(k) clearance on 2018-06-26, under approval number K173574.
What company makes DenSeeMammo?
DenSeeMammo is manufactured by Statlife.
What is the FDA product code for DenSeeMammo?
The FDA product code for DenSeeMammo is LLZ.
Other Devices by Statlife
Related Devices (Code: LLZ)
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.