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FDA 510(k)

Curapuls 670

K-Number: K243112 · 2025-06-25

Decision Date2025-06-25
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Curapuls 670 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 2025-06-25 under 510(k) number K243112. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curapuls 670?

Curapuls 670 is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K243112.

When did Curapuls 670 receive FDA 510(k) clearance?

Curapuls 670 received FDA 510(k) clearance on 2025-06-25, under 510(k) number K243112.

Who is the listed applicant for Curapuls 670?

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 Curapuls 670?

The FDA product code for Curapuls 670 is IMJ.

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.

Related Devices (Code: IMJ)

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.

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.