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FDA 510(k)

AirSpiral Heated Breathing Tube

K-Number: K162553 · 2018-12-20

ApplicantFisher & Paykel Healthcare
Decision Date2018-12-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirSpiral Heated Breathing Tube is a medical device manufactured by Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2018-12-20 under approval number K162553. 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 AirSpiral Heated Breathing Tube?

AirSpiral Heated Breathing Tube is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Fisher & Paykel Healthcare. The 510(k) number is K162553.

When was AirSpiral Heated Breathing Tube approved by the FDA?

AirSpiral Heated Breathing Tube received FDA 510(k) clearance on 2018-12-20, under approval number K162553.

What company makes AirSpiral Heated Breathing Tube?

AirSpiral Heated Breathing Tube is manufactured by Fisher & Paykel Healthcare.

What is the FDA product code for AirSpiral Heated Breathing Tube?

The FDA product code for AirSpiral Heated Breathing Tube is BTT.

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Other Devices by Fisher & Paykel Healthcare

K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit K220703F&P 950 Respiratory Humidifier K221338F&P Airvo 3 K222292F&P myAirvo 3

Related Devices (Code: BTT)

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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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