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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 the device name listed in this FDA 510(k) record. The listed applicant is Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) 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. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K230472.

When did Sonopuls 190 receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonopuls 190?

The FDA 510(k) record lists Enraf-Nonius, B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonopuls 190?

The FDA product code for Sonopuls 190 is IMI.

Other records listing Enraf-Nonius, B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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