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FDA 510(k)

Zenition 90

K-Number: K240224 · 2024-05-22

Decision Date2024-05-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Zenition 90 is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2024-05-22 under approval number K240224. 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 90?

Zenition 90 is a medical device that received FDA 510(k) clearance on 2024-05-22. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K240224.

When was Zenition 90 approved by the FDA?

Zenition 90 received FDA 510(k) clearance on 2024-05-22, under approval number K240224.

What company makes Zenition 90?

Zenition 90 is manufactured by Philips Medical Systems Nederlands B.V..

What is the FDA product code for Zenition 90?

The FDA product code for Zenition 90 is OWB.

Other Devices by Philips Medical Systems Nederlands B.V.

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Related Devices (Code: OWB)

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.