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FDA 510(k)

Compact II

K-Number: K251083 · 2025-09-12

ApplicantEnraf-Nonius, B.V.
Decision Date2025-09-12
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Compact II 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 2025-09-12 under 510(k) number K251083. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compact II?

Compact II is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K251083.

When did Compact II receive FDA 510(k) clearance?

Compact II received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251083.

Who is the listed applicant for Compact II?

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 Compact II?

The FDA product code for Compact II is IPF.

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.

K243112Curapuls 670K230472Sonopuls 190

Related Devices (Code: IPF)

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

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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