InnoSpire Go— 510(k) K170853

Substantially Equivalent

Respironics Respiratory Drug Delivery (Uk) , Ltd.

FDA 510(k) clearance K170853 for InnoSpire Go, Substantially Equivalent on 2017-11-02. Applicant: Respironics Respiratory Drug Delivery (Uk) , Ltd..

Clearance details

Applicant: Respironics Respiratory Drug Delivery (Uk) , Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2017-03-22
Decision date: 2017-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chichester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.