Miris Human Milk Analyzer (HMA)
K-Number: K223085 · 2023-09-29
ApplicantMiris AB
Decision Date2023-09-29
Product CodeQEI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Miris Human Milk Analyzer (HMA) is a medical device manufactured by Miris AB. It received FDA 510(k) clearance on 2023-09-29 under approval number K223085. The device is classified under product code QEI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Miris Human Milk Analyzer (HMA)?
Miris Human Milk Analyzer (HMA) is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Miris AB. The 510(k) number is K223085.
When was Miris Human Milk Analyzer (HMA) approved by the FDA?
Miris Human Milk Analyzer (HMA) received FDA 510(k) clearance on 2023-09-29, under approval number K223085.
What company makes Miris Human Milk Analyzer (HMA)?
Miris Human Milk Analyzer (HMA) is manufactured by Miris AB.
What is the FDA product code for Miris Human Milk Analyzer (HMA)?
The FDA product code for Miris Human Milk Analyzer (HMA) is QEI.
Other Devices by Miris AB
Related Devices (Code: QEI)
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.