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510(k) K223085

Miris Human Milk Analyzer (HMA) by Miris AB — Product Code QEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
September 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Breast Milk Macronutrients Test System
Device Class
Class II
Regulation Number
862.1493
Review Panel
CH
Submission Type

A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.

Other clearances by Miris AB

  • DEN180007 — Miris Human Milk Analyzer (December 21, 2018)

Other clearances for product code QEI

  • K234088 — Emily's Care Nourish Test System (Model 1) (May 3, 2024)
  • DEN180007 — Miris Human Milk Analyzer (December 21, 2018)