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FDA 510(k)

Cocoon Convective Warming System

K-Number: K181671 · 2019-05-02

ApplicantCare Essentials Pty, Ltd.
Decision Date2019-05-02
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cocoon Convective Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K181671. 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 Cocoon Convective Warming System?

Cocoon Convective Warming System is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Care Essentials Pty, Ltd.. The 510(k) number is K181671.

When did Cocoon Convective Warming System receive FDA 510(k) clearance?

Cocoon Convective Warming System received FDA 510(k) clearance on 2019-05-02, under 510(k) number K181671.

Who is the listed applicant for Cocoon Convective Warming System?

The FDA 510(k) record lists Care Essentials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cocoon Convective Warming System?

The FDA product code for Cocoon Convective Warming System is DWJ.

Other records listing Care Essentials Pty, Ltd. as applicant

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.

K232502Cocoon Convective Warming System, Model CWS7000K213907CareGUARD Sterilization Wrap

Related Devices (Code: DWJ)

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.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health Technologies

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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