SIDESTREAM PLUS— 510(k) K062689

Substantially Equivalent

Respironics , Ltd.

FDA 510(k) clearance K062689 for SIDESTREAM PLUS, Substantially Equivalent on 2007-02-16. Applicant: Respironics , Ltd..

Clearance details

Applicant: Respironics , Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2006-09-11
Decision date: 2007-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, NJ, US

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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.