FDA 510(k)

BONHAWA Respiratory Humidifier

K-Number: K223863 · 2023-10-13

Decision Date2023-10-13

Product CodeBTT

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BONHAWA Respiratory Humidifier is a medical device manufactured by Telesair, Inc.. It received FDA 510(k) clearance on 2023-10-13 under approval number K223863. 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 BONHAWA Respiratory Humidifier?

BONHAWA Respiratory Humidifier is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Telesair, Inc.. The 510(k) number is K223863.

When was BONHAWA Respiratory Humidifier approved by the FDA?

BONHAWA Respiratory Humidifier received FDA 510(k) clearance on 2023-10-13, under approval number K223863.

What company makes BONHAWA Respiratory Humidifier?

BONHAWA Respiratory Humidifier is manufactured by Telesair, Inc..

What is the FDA product code for BONHAWA Respiratory Humidifier?

The FDA product code for BONHAWA Respiratory Humidifier is BTT.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED

Other Devices by Telesair, Inc.

K251133AVEA disposable expiratory filter/water trap (11790)

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 K162242Comfort Flo Humidification SystemTeleflexmedical, 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.