FDA 510(k) Application Details - K223085

Device Classification Name	More FDA Info for this Device
510(K) Number	K223085
Device Name	Miris Human Milk Analyzer (HMA)
Applicant	Miris AB Danmarksgatan 26 Uppsala 75323 SE Other 510(k) Applications for this Company
Contact	Elin Hallen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	09/29/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review