HealthMammo
K-Number: K200905 · 2020-07-16
ApplicantZebra Medical Vision, Ltd.
Decision Date2020-07-16
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HealthMammo is a medical device manufactured by Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2020-07-16 under approval number K200905. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HealthMammo?
HealthMammo is a medical device that received FDA 510(k) clearance on 2020-07-16. It is manufactured by Zebra Medical Vision, Ltd.. The 510(k) number is K200905.
When was HealthMammo approved by the FDA?
HealthMammo received FDA 510(k) clearance on 2020-07-16, under approval number K200905.
What company makes HealthMammo?
HealthMammo is manufactured by Zebra Medical Vision, Ltd..
What is the FDA product code for HealthMammo?
The FDA product code for HealthMammo is QFM.
Other Devices by Zebra Medical Vision, Ltd.
Related Devices (Code: QFM)
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.