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FDA 510(k)

Comfort Flo Humidification System

K-Number: K162242 · 2017-01-19

ApplicantTeleflexmedical, Inc.
Decision Date2017-01-19
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Comfort Flo Humidification System is a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2017-01-19 under approval number K162242. 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 Comfort Flo Humidification System?

Comfort Flo Humidification System is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K162242.

When was Comfort Flo Humidification System approved by the FDA?

Comfort Flo Humidification System received FDA 510(k) clearance on 2017-01-19, under approval number K162242.

What company makes Comfort Flo Humidification System?

Comfort Flo Humidification System is manufactured by Teleflexmedical, Inc..

What is the FDA product code for Comfort Flo Humidification System?

The FDA product code for Comfort Flo Humidification System is BTT.

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Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. 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 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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