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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 a medical device manufactured by Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2019-05-02 under approval 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. It is manufactured by Care Essentials Pty, Ltd.. The 510(k) number is K181671.

When was Cocoon Convective Warming System approved by the FDA?

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

What company makes Cocoon Convective Warming System?

Cocoon Convective Warming System is manufactured by Care Essentials Pty, Ltd..

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

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

Related Clinical Trials

NCT04011462 Perioperative Normothermia: Temperature and Prewarming Methods COMPLETED NCT07365735 TearCare MGX™ System With and Without Warming Hold ACTIVE_NOT_RECRUITING

Other Devices by Care Essentials Pty, Ltd.

K213907CareGUARD Sterilization Wrap K232502Cocoon Convective Warming System, Model CWS7000

Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, Inc.

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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