FDA 510(k)

Getinge Series Warming Cabinet

K-Number: K153713 · 2016-06-07

Decision Date2016-06-07

Product CodeLHC

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Getinge Series Warming Cabinet is the device name listed in this FDA 510(k) record. The listed applicant is Getinge Sourcing, LLC. It received FDA 510(k) clearance on 2016-06-07 under 510(k) number K153713. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Getinge Series Warming Cabinet?

Getinge Series Warming Cabinet is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Getinge Sourcing, LLC. The 510(k) number is K153713.

When did Getinge Series Warming Cabinet receive FDA 510(k) clearance?

Getinge Series Warming Cabinet received FDA 510(k) clearance on 2016-06-07, under 510(k) number K153713.

Who is the listed applicant for Getinge Series Warming Cabinet?

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

What is the FDA product code for Getinge Series Warming Cabinet?

The FDA product code for Getinge Series Warming Cabinet is LHC.

Related Devices (Code: LHC)

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.

K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.

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.