FDA 510(k), K212773, ARDO Alyssa

FDA 510(k), K212773, ARDO Alyssa

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510(K) Number: K212773
Device Name: ARDO Alyssa
Manufacturer: ARDO Medical AG
Device Classification Name: Pump, Breast, Powered
Regulation Number: 884.5160
Classification Product Code: HGX
Date Received: 08/31/2021
Decision Date: 04/15/2022
Regulation Medical Specialty: Obstetrics/Gynecology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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