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FDA 510(k)

BONHAWA Respiratory Humidifier

K-Number: K223863 · 2023-10-13

ApplicantTelesair, Inc.
Decision Date2023-10-13
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BONHAWA Respiratory Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Telesair, Inc.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) 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. The listed applicant is Telesair, Inc.. The 510(k) number is K223863.

When did BONHAWA Respiratory Humidifier receive FDA 510(k) clearance?

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

Who is the listed applicant for BONHAWA Respiratory Humidifier?

The FDA 510(k) record lists Telesair, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONHAWA Respiratory Humidifier?

The FDA product code for BONHAWA Respiratory Humidifier is BTT.

Other records listing Telesair, Inc. 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.

K251133AVEA disposable expiratory filter/water trap (11790)

Related Devices (Code: BTT)

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.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

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.

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