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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Miris AB. It received FDA 510(k) clearance on 2023-09-29 under 510(k) 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. The listed applicant is Miris AB. The 510(k) number is K223085.

When did Miris Human Milk Analyzer (HMA) receive FDA 510(k) clearance?

Miris Human Milk Analyzer (HMA) received FDA 510(k) clearance on 2023-09-29, under 510(k) number K223085.

Who is the listed applicant for Miris Human Milk Analyzer (HMA)?

The FDA 510(k) record lists Miris AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Miris Human Milk Analyzer (HMA)?

The FDA product code for Miris Human Milk Analyzer (HMA) is QEI.

Related Devices (Code: QEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234088Emily's Care Nourish Test System (Model 1)Lactation Lab, Inc.

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.

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