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FDA 510(k)

PainFreeze II

K-Number: K232674 · 2024-02-12

ApplicantNuance Medical, LLC
Decision Date2024-02-12
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

PainFreeze II is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K232674. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PainFreeze II?

PainFreeze II is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Nuance Medical, LLC. The 510(k) number is K232674.

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

PainFreeze II received FDA 510(k) clearance on 2024-02-12, under 510(k) number K232674.

Who is the listed applicant for PainFreeze II?

The FDA 510(k) record lists Nuance Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PainFreeze II?

The FDA product code for PainFreeze II is MLY.

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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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