One Mum Pumpset
K-Number: K172067 · 2017-11-29
ApplicantArdo Medical AG
Decision Date2017-11-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
One Mum Pumpset is a medical device manufactured by Ardo Medical AG. It received FDA 510(k) clearance on 2017-11-29 under approval number K172067. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the One Mum Pumpset?
One Mum Pumpset is a medical device that received FDA 510(k) clearance on 2017-11-29. It is manufactured by Ardo Medical AG. The 510(k) number is K172067.
When was One Mum Pumpset approved by the FDA?
One Mum Pumpset received FDA 510(k) clearance on 2017-11-29, under approval number K172067.
What company makes One Mum Pumpset?
One Mum Pumpset is manufactured by Ardo Medical AG.
What is the FDA product code for One Mum Pumpset?
The FDA product code for One Mum Pumpset is HGX.
Other Devices by Ardo Medical AG
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.