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FDA 510(k)

InnoSpire Go

K-Number: K170853 · 2017-11-02

ApplicantRespironics Respiratory Drug Delivery (Uk) , Ltd.
Decision Date2017-11-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InnoSpire Go is a medical device manufactured by Respironics Respiratory Drug Delivery (Uk) , Ltd.. It received FDA 510(k) clearance on 2017-11-02 under approval number K170853. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InnoSpire Go?

InnoSpire Go is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Respironics Respiratory Drug Delivery (Uk) , Ltd.. The 510(k) number is K170853.

When was InnoSpire Go approved by the FDA?

InnoSpire Go received FDA 510(k) clearance on 2017-11-02, under approval number K170853.

What company makes InnoSpire Go?

InnoSpire Go is manufactured by Respironics Respiratory Drug Delivery (Uk) , Ltd..

What is the FDA product code for InnoSpire Go?

The FDA product code for InnoSpire Go is CAF.

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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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