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FDA 510(k)

Curapuls 670

K-Number: K243112 · 2025-06-25

ApplicantEnraf-Nonius, B.V.
Decision Date2025-06-25
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Curapuls 670 is a medical device manufactured by Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2025-06-25 under approval 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. It is manufactured by Enraf-Nonius, B.V.. The 510(k) number is K243112.

When was Curapuls 670 approved by the FDA?

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

What company makes Curapuls 670?

Curapuls 670 is manufactured by Enraf-Nonius, B.V..

What is the FDA product code for Curapuls 670?

The FDA product code for Curapuls 670 is IMJ.

Other Devices by Enraf-Nonius, B.V.

K230472Sonopuls 190 K251083Compact II

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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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