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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 the device name listed in this FDA 510(k) record. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) 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. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. The 510(k) number is K170853.

When did InnoSpire Go receive FDA 510(k) clearance?

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

Who is the listed applicant for InnoSpire Go?

The FDA 510(k) record lists Respironics Respiratory Drug Delivery (Uk) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InnoSpire Go?

The FDA product code for InnoSpire Go is CAF.

Related Devices (Code: CAF)

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.

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Official Source

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