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FDA 510(k)

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

K-Number: K161314 · 2016-07-06

ApplicantFlexicare Medical Limited.
Decision Date2016-07-06
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2016-07-06 under approval number K161314. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K161314.

When was FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE approved by the FDA?

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE received FDA 510(k) clearance on 2016-07-06, under approval number K161314.

What company makes FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is manufactured by Flexicare Medical Limited..

What is the FDA product code for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

The FDA product code for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is BTT.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED

Other Devices by Flexicare Medical Limited.

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Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare

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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