Zenition 50
K-Number: K183101 · 2018-12-31
Decision Date2018-12-31
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Zenition 50 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-12-31 under approval number K183101. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zenition 50?
Zenition 50 is a medical device that received FDA 510(k) clearance on 2018-12-31. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K183101.
When was Zenition 50 approved by the FDA?
Zenition 50 received FDA 510(k) clearance on 2018-12-31, under approval number K183101.
What company makes Zenition 50?
Zenition 50 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Zenition 50?
The FDA product code for Zenition 50 is OWB.
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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.