510(k) K223085
- Device
- Miris Human Milk Analyzer (HMA)
- Applicant
- Miris AB
- 510(k) number
- K223085
- Product code
- QEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-29
- Date received
- 2022-09-30
- Regulation
- 862.1493
- Classification name
- Breast Milk Macronutrients Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elin Hallen
- Address
- Danmarksgatan 26 Uppsala SE 75323 75323
FDA Registration Numbers#
- 3013887826