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FDA 510(k)

Sonopuls 190

K-Number: K230472 · 2023-10-24

ApplicantEnraf-Nonius, B.V.
Decision Date2023-10-24
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Sonopuls 190 is a medical device manufactured by Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2023-10-24 under approval number K230472. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonopuls 190?

Sonopuls 190 is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by Enraf-Nonius, B.V.. The 510(k) number is K230472.

When was Sonopuls 190 approved by the FDA?

Sonopuls 190 received FDA 510(k) clearance on 2023-10-24, under approval number K230472.

What company makes Sonopuls 190?

Sonopuls 190 is manufactured by Enraf-Nonius, B.V..

What is the FDA product code for Sonopuls 190?

The FDA product code for Sonopuls 190 is IMI.

Other Devices by Enraf-Nonius, B.V.

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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.

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