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FDA 510(k)

Salter Labs Bubble Humidifier

K-Number: K161719 · 2017-09-21

ApplicantSalter Labs
Decision Date2017-09-21
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Salter Labs Bubble Humidifier is a medical device manufactured by Salter Labs. It received FDA 510(k) clearance on 2017-09-21 under approval number K161719. 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 Salter Labs Bubble Humidifier?

Salter Labs Bubble Humidifier is a medical device that received FDA 510(k) clearance on 2017-09-21. It is manufactured by Salter Labs. The 510(k) number is K161719.

When was Salter Labs Bubble Humidifier approved by the FDA?

Salter Labs Bubble Humidifier received FDA 510(k) clearance on 2017-09-21, under approval number K161719.

What company makes Salter Labs Bubble Humidifier?

Salter Labs Bubble Humidifier is manufactured by Salter Labs.

What is the FDA product code for Salter Labs Bubble Humidifier?

The FDA product code for Salter Labs Bubble Humidifier is BTT.

Other Devices by Salter Labs

K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

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 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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