510(k) DEN180007
DEN180007 is an FDA 510(k) premarket notification submitted by Miris AB for the device "Miris Human Milk Analyzer". The FDA issued a decision of De Novo Granted on December 21, 2018. The device falls under product code QEI (Breast Milk Macronutrients Test System), a Class II device regulated under 21 CFR 862.1493. Miris AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 21, 2018
- Date Received
- February 12, 2018
- Clearance Type
- Direct
- 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.