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FDA 510(k)

WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM

K-Number: K121720 · 2012-08-20

ApplicantWelkins, LLC
Decision Date2012-08-20
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Welkins, LLC. It received FDA 510(k) clearance on 2012-08-20 under 510(k) number K121720. 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 WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM?

WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-20. The listed applicant is Welkins, LLC. The 510(k) number is K121720.

When did WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM receive FDA 510(k) clearance?

WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM received FDA 510(k) clearance on 2012-08-20, under 510(k) number K121720.

Who is the listed applicant for WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM?

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

What is the FDA product code for WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM?

The FDA product code for WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM 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.

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