FDA 510(k)

Mistral-Air Warming Unit

K-Number: K171234 · 2017-05-26

ApplicantThe Surgical Company International BV (As the 37company)

Decision Date2017-05-26

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Mistral-Air Warming Unit is a medical device manufactured by The Surgical Company International BV (As the 37company). It received FDA 510(k) clearance on 2017-05-26 under approval number K171234. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mistral-Air Warming Unit?

Mistral-Air Warming Unit is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by The Surgical Company International BV (As the 37company). The 510(k) number is K171234.

When was Mistral-Air Warming Unit approved by the FDA?

Mistral-Air Warming Unit received FDA 510(k) clearance on 2017-05-26, under approval number K171234.

What company makes Mistral-Air Warming Unit?

Mistral-Air Warming Unit is manufactured by The Surgical Company International BV (As the 37company).

What is the FDA product code for Mistral-Air Warming Unit?

The FDA product code for Mistral-Air Warming Unit is DWJ.

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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.